| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| JHH | Electrophoretic Method, Lecithin/Sphingomyelin Ratio | 第 2 类 | 21 CFR 862.1455 | |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 第 2 类 | 21 CFR 862.1155 | 375 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 第 2 类 | 21 CFR 862.1155 | 96 |
| JHL | Microdensitometry Method, Lipoproteins | 第 1 类 | 21 CFR 862.1475 | 1 |
| JHM | Colorimetric Method, Lipoproteins | 第 1 类 | 21 CFR 862.1475 | 9 |
| JHN | Turbidimetric Method, Lipoproteins | 第 1 类 | 21 CFR 862.1475 | 7 |
| JHO | Electrophoretic Separation, Lipoproteins | 第 1 类 | 21 CFR 862.1475 | 26 |
| JHP | Radial Immunodiffusion, Lipoproteins | 第 1 类 | 21 CFR 862.1475 | |
| JHQ | Nephelometric Method, Lipoproteins | 第 1 类 | 21 CFR 862.1475 | 1 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 第 2 类 | 21 CFR 862.1215 | 38 |
| JHT | Chromatographic Separation, Cpk Isoenzymes | 第 2 类 | 21 CFR 862.1215 | 21 |
| JHW | U.V. Method, Cpk Isoenzymes | 第 2 类 | 21 CFR 862.1215 | 27 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 第 2 类 | 21 CFR 862.1215 | 48 |
| JHY | Colorimetric Method, Cpk Or Isoenzymes | 第 2 类 | 21 CFR 862.1215 | 40 |
| JIA | Enzymatic Methods, Galactose | 第 1 类 | 21 CFR 862.1310 | 9 |
| JIB | U.V. Method, Galactose | 第 1 类 | 21 CFR 862.1310 | |
| JIC | Colorimetric Method, Galactose | 第 1 类 | 21 CFR 862.1310 | |
| JID | Photometric Method, Ammonia | 第 1 类 | 21 CFR 862.1065 | 3 |
| JIE | Method, Ion-Exchange, Ammonia | 第 1 类 | 21 CFR 862.1065 | |
| JIF | Enzymatic Method, Ammonia | 第 1 类 | 21 CFR 862.1065 | 30 |
| JIG | Electrode, Ion-Specific Method, Ammonia | 第 1 类 | 21 CFR 862.1065 | |
| JIJ | Wet Ash Method, Protein-Bound Iodine | 第 1 类 | 21 CFR 862.1640 | |
| JIK | Dry Ash Method, Protein-Bound Iodine | 第 1 类 | 21 CFR 862.1640 | |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 第 2 类 | 21 CFR 862.1340 | 81 |
| JIM | Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) | 第 2 类 | 21 CFR 862.1340 | 2 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 第 1 类 | 21 CFR 862.1435 | 24 |
| JIQ | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | 第 1 类 | 21 CFR 862.1645 | 13 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 第 1 类 | 21 CFR 862.1645 | 38 |
| JIS | Calibrator, Primary | 第 2 类 | 21 CFR 862.1150 | 130 |
| JIT | Calibrator, Secondary | 第 2 类 | 21 CFR 862.1150 | 245 |
| JIW | Calibrator, Surrogate | 第 2 类 | 21 CFR 862.1150 | 17 |
| JIX | Calibrator, Multi-Analyte Mixture | 第 2 类 | 21 CFR 862.1150 | 302 |
| JIY | Photometric Method, Iron (Non-Heme) | 第 1 类 | 21 CFR 862.1410 | 67 |
| JIZ | Atomic Absorption, Iron (Non-Heme) | 第 1 类 | 21 CFR 862.1410 | |
| JJA | Radio-Labeled Iron Method, Iron (Non-Heme) | 第 1 类 | 21 CFR 862.1410 | 4 |
| JJB | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant | 第 1 类 | 21 CFR 862.1115 | 5 |
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Us | 第 1 类 | 21 CFR 862.2150 | 32 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 第 1 类 | 21 CFR 862.2160 | 208 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 第 1 类 | 21 CFR 862.2170 | 57 |
| JJG | Analyzer, Chemistry, Centrifugal, For Clinical Use | 第 1 类 | 21 CFR 862.2140 | 30 |
| JJH | Clinical Sample Concentrator | 第 1 类 | 21 CFR 862.2310 | 15 |
| JJI | Analyzer, Enzyme, For Clinical Use | 第 1 类 | 21 CFR 862.2500 | 8 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 第 1 类 | 21 CFR 862.2320 | 63 |
| JJK | Oncometer, Plasma, For Clinical Use | 第 1 类 | 21 CFR 862.2720 | 4 |
| JJL | Plasma Viscometer For Clinical Use | 第 1 类 | 21 CFR 862.2920 | 1 |
| JJM | Osmometer For Clinical Use | 第 1 类 | 21 CFR 862.2730 | 12 |
| JJN | Apparatus, Electrophoresis, For Clinical Use | 第 1 类 | 21 CFR 862.2485 | 34 |
| JJO | Flame Emission Photometer For Clinical Use | 第 1 类 | 21 CFR 862.2540 | 22 |
| JJP | Electrode, Ion Selective (Non-Specified) | 第 1 类 | 21 CFR 862.2050 | 3 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 第 1 类 | 21 CFR 862.2300 | 258 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 第 1 类 | 21 CFR 862.1660 | 17 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 第 1 类 | 21 CFR 862.1660 | 67 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 第 1 类 | 21 CFR 862.1660 | 97 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 第 1 类 | 21 CFR 862.1660 | 61 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 第 1 类 | 21 CFR 862.1660 | 493 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 第 1 类 | 21 CFR 862.1660 | 673 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 第 2 类 | 21 CFR 862.1675 | 236 |
| JKB | Radioimmunoassay, Compound S (11-Deoxycortisol) | 第 1 类 | 21 CFR 862.1185 | 1 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 第 1 类 | 21 CFR 862.1245 | 28 |
| JKD | Radioimmunoassay, C-Peptides Of Proinsulin | 第 1 类 | 21 CFR 862.1135 | 10 |
| JKF | Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Deh | 第 1 类 | 21 CFR 862.1380 | 2 |
| JKG | L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase | 第 1 类 | 21 CFR 862.1420 | 1 |
| JKH | Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehyd | 第 1 类 | 21 CFR 862.1420 | 1 |
| JKJ | Fluorometric Measurement, Porphyrins | 第 1 类 | 21 CFR 862.1595 | 3 |
| JKL | Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry | 第 1 类 | 21 CFR 862.1060 | 2 |
| JKP | Chromium-51, Blood Volume | 第 1 类 | 21 CFR 862.1130 | 1 |
| JKR | Radioimmunoassay, Calcitonin | 第 2 类 | 21 CFR 862.1140 | 20 |
| JKW | N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin | 第 1 类 | 21 CFR 862.1180 | |
| JKX | N-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin | 第 1 类 | 21 CFR 862.1180 | |
| JKY | Oxalydihydrazide (Spectroscopic), Copper | 第 1 类 | 21 CFR 862.1190 | |
| JKZ | Diethyldithiocarbamate (Colorimetric), Copper | 第 1 类 | 21 CFR 862.1190 | |
| JLA | Conversion To Creatinine, Creatine | 第 1 类 | 21 CFR 862.1210 | 2 |
| JLB | Atp And Creatine Kinase (Enzymatic), Creatine | 第 1 类 | 21 CFR 862.1210 | 3 |
| JLC | Nitroprusside Reaction (Qualitative, Urine), Cystine | 第 1 类 | 21 CFR 862.1240 | 2 |
| JLD | Chromatographic, Cystine | 第 1 类 | 21 CFR 862.1240 | |
| JLE | Radioimmunoassay, Desoxycorticosterone | 第 1 类 | 21 CFR 862.1250 | |
| JLF | Radioimmunoassay, Etiocholanolone | 第 1 类 | 21 CFR 862.1285 | |
| JLG | Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids | 第 1 类 | 21 CFR 862.1290 | 2 |
| JLH | Titrimetric, Fatty Acids | 第 1 类 | 21 CFR 862.1290 | 1 |
| JLI | Tetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid | 第 1 类 | 21 CFR 862.1305 | |
| JLJ | Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate | 第 2 类 | 21 CFR 862.1315 | 1 |
| JLK | Sodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity | 第 1 类 | 21 CFR 862.1320 | |
| JLL | Tubeless Analysis, Gastric Acidity | 第 1 类 | 21 CFR 862.1320 | |
| JLN | Chromatographic, Glutathione | 第 1 类 | 21 CFR 862.1365 | |
| JLO | Enzymatic (Glutathione Reductase), Glutathione | 第 1 类 | 21 CFR 862.1365 | |
| JLP | Spectrophotometric Method, Pregnanediol | 第 1 类 | 21 CFR 862.1605 | 1 |
| JLQ | Spectrophotometric Method, Pregnanetriol | 第 1 类 | 21 CFR 862.1610 | |
| JLR | Gas Chromatography, Pregnanetriol | 第 1 类 | 21 CFR 862.1610 | |
| JLS | Radioimmunoassay, Progesterone | 第 1 类 | 21 CFR 862.1620 | 57 |
| JLT | Acid, Pyruvic, Enzymatic (U.V.) | 第 1 类 | 21 CFR 862.1655 | |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 第 2 类 | 21 CFR 862.1690 | 242 |
| JLX | Radioimmunoassay, 17-Hydroxyprogesterone | 第 1 类 | 21 CFR 862.1395 | 19 |
| JLY | Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid | 第 1 类 | 21 CFR 862.1255 | |
| JLZ | Nadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric Acid | 第 1 类 | 21 CFR 862.1255 | |
| JMA | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | 第 1 类 | 21 CFR 862.1095 | 3 |
| JMD | Radioimmunoassay, Total Estrogens, Nonpregnancy | 第 1 类 | 21 CFR 862.1275 | 2 |
| JME | Radioimmunoassay, Glucagon | 第 1 类 | 21 CFR 862.1335 | 3 |
| JMF | Radioimmunoassay, Human Placental Lactogen | 第 2 类 | 21 CFR 862.1585 | 11 |
| JMI | Chromatographic, Histidine | 第 1 类 | 21 CFR 862.1375 | |
| JMJ | Microbiological, Histidine | 第 1 类 | 21 CFR 862.1375 | |
| JMK | Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase | 第 1 类 | 21 CFR 862.1380 | 16 |
| JMM | Column Chromatography & Color Development, Hydroxyproline | 第 1 类 | 21 CFR 862.1400 | 21 |
| JMN | Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline | 第 1 类 | 21 CFR 862.1400 | |
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | 第 1 类 | 21 CFR 862.1415 | 46 |
| JMQ | M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase) | 第 1 类 | 21 CFR 862.1490 | |
| JMR | Immunochemical, Lysozyme (Muramidase) | 第 1 类 | 21 CFR 862.1490 | |
| JMS | Acid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase | 第 1 类 | 21 CFR 862.1500 | |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 第 1 类 | 21 CFR 862.1510 | 13 |
| JMW | 2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen) | 第 1 类 | 21 CFR 862.1515 | |
| JMX | Ninhydrin, Nitrogen (Amino-Nitrogen) | 第 1 类 | 21 CFR 862.1515 | 2 |
| JMY | Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transf | 第 1 类 | 21 CFR 862.1535 | |
| JMZ | Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmol | 第 1 类 | 21 CFR 862.1540 | 2 |
| JNA | Vapor Pressure, Osmolality Of Serum & Urine | 第 1 类 | 21 CFR 862.1540 | |
| JNB | Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | 第 2 类 | 21 CFR 862.1555 | 15 |
| JNC | Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine | 第 2 类 | 21 CFR 862.1555 | |
| JND | Nadp Reduction, 6-Phosphogluconate Dehydrogenase | 第 1 类 | 21 CFR 862.1565 | |
| JNE | Glucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase | 第 1 类 | 21 CFR 862.1570 | |
| JNF | Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen | 第 1 类 | 21 CFR 862.1590 | 1 |
| JNG | Radioimmunoassay, Pregnenolone | 第 1 类 | 21 CFR 862.1615 | |
| JNJ | Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase | 第 1 类 | 21 CFR 862.1650 | |
| JNK | Beta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase | 第 1 类 | 21 CFR 862.1670 | |
| JNN | P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | 第 1 类 | 21 CFR 862.1725 | |
| JNO | N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin | 第 1 类 | 21 CFR 862.1725 | 7 |
| JNP | Infrared Spectroscopy Measurement, Urinary Calculi (Stone) | 第 1 类 | 21 CFR 862.1780 | |
| JNQ | Qualitative Chemical Reactions, Urinary Calculi (Stone) | 第 1 类 | 21 CFR 862.1780 | |
| JNS | Stannous Chloride - Hydrazine, Phospholipids | 第 1 类 | 21 CFR 862.1575 | |
| JNT | Chromatographic, Phospholipids | 第 1 类 | 21 CFR 862.1575 | 3 |
| JNX | Membrane Osmometry, Plasma Oncometry | 第 1 类 | 21 CFR 862.1530 | |
| JNY | Glyceralde-3-Phosphate, Nadh (Enzymatic), Triose Phosphate Isomerase | 第 1 类 | 21 CFR 862.1720 | |
| JNZ | Fluorometric, Uroporphyrin | 第 1 类 | 21 CFR 862.1790 | |
| JOA | Acid, Trifluoroacetic, Vitamin A, Hexane Extraction | 第 1 类 | 21 CFR 862.1805 | |
| JOB | Hexane Extraction, Fluorescence, Vitamin E | 第 1 类 | 21 CFR 862.1815 | 1 |
| JOC | Colorimetric, Xylose | 第 1 类 | 21 CFR 862.1820 | 1 |
| JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | 第 1 类 | 21 CFR 862.1360 | 33 |
| JQA | Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes | 第 1 类 | 21 CFR 862.1360 | |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | 第 1 类 | 21 CFR 862.1360 | 52 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 第 1 类 | 21 CFR 862.2050 | 38 |
| JQD | Resin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capa | 第 1 类 | 21 CFR 862.1415 | |
| JQE | Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity | 第 1 类 | 21 CFR 862.1415 | 6 |
| JQF | Bathophenanthroline, Iron Binding Capacity | 第 1 类 | 21 CFR 862.1415 | 8 |
| JQG | Radiometric, Fe59, Iron Binding Capacity | 第 1 类 | 21 CFR 862.1415 | 5 |
| JQH | Trinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen) | 第 1 类 | 21 CFR 862.1515 | |
| JQI | Rotating Disc, Plasma Viscometry | 第 1 类 | 21 CFR 862.1475 | |
| JQJ | Densitometeric, Protein Fractionation | 第 1 类 | 21 CFR 862.1630 | 1 |
| JQK | Immunodiffusion, Protein Fractionation | 第 1 类 | 21 CFR 862.1630 | 1 |
| JQL | Spectrophotometric, Uroporphyrin | 第 1 类 | 21 CFR 862.1790 | |
| JQM | P-Bromoaniline, Xylose | 第 1 类 | 21 CFR 862.1820 | |
| JQN | Colorimetric, Mucopolysaccharides | 第 1 类 | 21 CFR 862.1505 | 2 |
| JQO | Balance, Analytical | 第 1 类 | 21 CFR 862.2050 | |
| JQP | Calculator/Data Processing Module, For Clinical Use | 第 1 类 | 21 CFR 862.2100 | 78 |
| JQQ | Dialyzer | 第 1 类 | 21 CFR 862.2050 | 1 |
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Cl | 第 1 类 | 21 CFR 862.2400 | 18 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 第 1 类 | 21 CFR 862.2750 | 140 |
| JQX | Nephelometer, For Clinical Use | 第 1 类 | 21 CFR 862.2700 | 14 |
| JQY | Ph Meter | 第 1 类 | 21 CFR 862.2050 | 8 |
| JQZ | Polarimeter | 第 1 类 | 21 CFR 862.2050 | 1 |
| JRA | Microtitrator, For Clinical Use | 第 1 类 | 21 CFR 862.2680 | 1 |
| JRB | Micro Mixer | 第 1 类 | 21 CFR 862.2050 | |
| JRC | Micro Pipette | 第 1 类 | 21 CFR 862.2050 | 6 |
| JRE | Refractometer For Clinical Use | 第 1 类 | 21 CFR 862.2800 | 13 |
| JRG | Block, Heating | 第 1 类 | 21 CFR 862.2050 | 3 |
| JRI | Cuvette, Thermostated | 第 1 类 | 21 CFR 862.2050 | 4 |
| JRJ | Unit, Drying | 第 1 类 | 21 CFR 862.2050 | 1 |
| JRK | Evaporator | 第 1 类 | 21 CFR 862.2050 | |
| JRL | Unit, Filter, Membrane | 第 1 类 | 21 CFR 862.2050 | 9 |
| JRM | Freezer | 第 1 类 | 21 CFR 862.2050 | 7 |
| JRO | Blender/Mixer | 第 1 类 | 21 CFR 862.2050 | |
| JRQ | Shaker/Stirrer | 第 1 类 | 21 CFR 862.2050 | 8 |
| JRR | Regulator, Temperature | 第 1 类 | 21 CFR 862.2050 | 4 |
| JRS | Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Os | 第 1 类 | 21 CFR 862.2050 | |
| JSQ | Chromatography For Bacterial Identification | 第 1 类 | 21 CFR 862.2250 | 3 |
| JXQ | Monitor, U.V., Glc | 第 1 类 | 21 CFR 862.2250 | |
| JXR | Atomic Absorption Spectrophotometer, General Use | 第 1 类 | 21 CFR 862.2850 | 29 |
| KEA | Resins, Ion-Exchange | 第 1 类 | 21 CFR 862.2230 | 9 |
| KHM | Nephelometric, Amylase | 第 2 类 | 21 CFR 862.1070 | 6 |
| KHO | Fluorometer, For Clinical Use | 第 1 类 | 21 CFR 862.2560 | 38 |
| KHP | Acid, Lactic, Enzymatic Method | 第 1 类 | 21 CFR 862.1450 | 27 |
| KHQ | Radioassay, Triiodothyronine Uptake | 第 2 类 | 21 CFR 862.1715 | 93 |
| KHS | Enzymatic, Carbon-Dioxide | 第 2 类 | 21 CFR 862.1160 | 86 |
| KIE | Apparatus, High Pressure Liquid Chromatography | 第 1 类 | 21 CFR 862.2260 | 25 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 第 2 类 | 21 CFR 862.1700 | 86 |
| KLJ | Nad Reduction (U.V.), Phosphohexose Isomerase | 第 1 类 | 21 CFR 862.1570 | 1 |
| KMS | Phenolphthalein Colorimetry, Carbon-Dioxide | 第 2 类 | 21 CFR 862.1160 | 5 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 第 1 类 | 21 CFR 862.1775 | 118 |
| KQN | Radioassay, Angiotensin Converting Enzyme | 第 2 类 | 21 CFR 862.1090 | 8 |
| KQO | Automated Urinalysis System | 第 1 类 | 21 CFR 862.2900 | 46 |
| KQP | Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | 第 2 类 | 21 CFR 862.1315 | 7 |
| KWW | Radioimmunoassay, Cholyglycine, Bile Acids | 第 2 类 | 21 CFR 862.1177 | 6 |
| KWX | Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids | 第 2 类 | 21 CFR 862.1187 | 2 |
| KZQ | Chromatography(Gas), Clinical Use | 第 1 类 | 21 CFR 862.2250 | 12 |
| KZR | Chromatography (Liquid, Gel), Clinical Use | 第 1 类 | 21 CFR 862.2260 | 15 |
| KZS | Chromatography (Thin Layer), Clinical Use | 第 1 类 | 21 CFR 862.2270 | |
| LBR | Ldl & Vldl Precipitation, Hdl | 第 1 类 | 21 CFR 862.1475 | 66 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 第 1 类 | 21 CFR 862.1475 | 80 |
| LBT | Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl | 第 1 类 | 21 CFR 862.1475 | 8 |
| LCH | Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical | 第 1 类 | 21 CFR 862.1660 | 9 |
| LCI | Automated Radioimmunoassay Systems, For Clinical Use | 第 1 类 | 21 CFR 862.2050 | 3 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 第 2 类 | 21 CFR 862.1155 | 226 |
| LDM | Instrumentation, High Pressure Liquid Chromatography | 第 1 类 | 21 CFR 862.2260 | 19 |
| LEQ | Detectors, Electrochemical, Liquid Chromatography | 第 1 类 | 21 CFR 862.2260 | 4 |