| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| LFP | Conductivity Rate, Urea Nitrogen | 第 2 类 | 21 CFR 862.1770 | 6 |
| LFQ | Acid, Uric, Acid Reduction Of Ferric Ion | 第 1 类 | 21 CFR 862.1775 | 5 |
| LFR | Glucose Dehydrogenase, Glucose | 第 2 类 | 21 CFR 862.1345 | 73 |
| LFS | Radioreceptor Assay, Human Chorionic Gonadotropin | 第 2 类 | 21 CFR 862.1155 | |
| LIG | Radioassay, Intrinsic Factor Blocking Antibody | 第 2 类 | 21 CFR 862.1810 | 8 |
| LNW | Paper, Obstetric Ph | 第 1 类 | 21 CFR 862.1550 | 4 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | 第 2 类 | 21 CFR 862.1377 | 29 |
| LPT | System, Test, Urinary Methylmalonic Acid | 第 2 类 | 21 CFR 862.1509 | |
| LPW | System, Test, Oxalate | 第 1 类 | 21 CFR 862.1542 | 1 |
| LTB | Cyclosporine Radioimmunoassay | 第 2 类 | 21 CFR 862.1235 | 1 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Spec | 第 1 类 | 21 CFR 862.2050 | 3 |
| MAR | Cyclosporine And Metabolites Serum Assay | 第 2 类 | 21 CFR 862.1235 | |
| MGS | High Performance Liquid Chromatography For Cyclosporine | 第 2 类 | 21 CFR 862.1235 | |
| MGU | Fluorescence Polarization Immunoassay For Cyclosporine | 第 2 类 | 21 CFR 862.1235 | |
| MGV | Radioimmunoassay For Cyclosporine | 第 2 类 | 21 CFR 862.1235 | |
| MJX | Kit, Serological, Positive Control | 第 1 类 | 21 CFR 862.1660 | 7 |
| MJY | Kit, Serological, Negative Control | 第 1 类 | 21 CFR 862.1660 | 1 |
| MJZ | Kit, Direct Antigen, Positive Control | 第 1 类 | 21 CFR 862.1660 | 3 |
| MKA | Kit, Direct Antigen, Negative Control | 第 1 类 | 21 CFR 862.1660 | |
| MKW | Cyclosporine | 第 2 类 | 21 CFR 862.1235 | 9 |
| MLM | Enzyme Immunoassay, Tracrolimus | 第 2 类 | 21 CFR 862.1678 | 9 |
| MMI | Immunoassay Method, Troponin Subunit | 第 2 类 | 21 CFR 862.1215 | 95 |
| MPG | Urinary Carbohydrate Analysis Kit | 第 1 类 | 21 CFR 862.1505 | 1 |
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | 第 1 类 | 21 CFR 862.1113 | 17 |
| MRG | System, Test, Vitamin D | 第 2 类 | 21 CFR 862.1825 | 46 |
| MRR | System, Test, Low Density, Lipoprotein | 第 1 类 | 21 CFR 862.1475 | 31 |
| MRV | Drink, Glucose Tolerance | 第 2 类 | 21 CFR 862.1345 | 3 |
| MSJ | Apolipoproteins | 第 1 类 | 21 CFR 862.1475 | 50 |
| MSM | System, Test, Lipoprotein(A) | 第 1 类 | 21 CFR 862.1475 | |
| MYT | Biosensor, Immunoassay, Cpk Or Isoenzymes | 第 2 类 | 21 CFR 862.1215 | 3 |
| MZU | System, Test, Sodium, Enzymatic Method | 第 2 类 | 21 CFR 862.1665 | 2 |
| MZV | Test, System, Potassium, Enzymatic Method | 第 2 类 | 21 CFR 862.1600 | 4 |
| NAK | System, Test, Biotinidase | 第 2 类 | 21 CFR 862.1118 | 5 |
| NAL | Test, Immunoassay, Biosensor, Hcg | 第 2 类 | 21 CFR 862.1155 | 2 |
| NAO | Test, Carbohydrate Deficient Transferrin | 第 1 类 | 21 CFR 862.1360 | 3 |
| NAQ | Lipoprotein, High Density, Hdl, Over The Counter | 第 1 类 | 21 CFR 862.1175 | 2 |
| NBC | Test, Natriuretic Peptide | 第 2 类 | 21 CFR 862.1117 | 45 |
| NBW | System, Test, Blood Glucose, Over The Counter | 第 2 类 | 21 CFR 862.1345 | 510 |
| NDR | Enzyme Immunoassay, Inhibin-A | 第 1 类 | 21 CFR 862.1260 | 1 |
| NDY | Test, Cystatin C | 第 2 类 | 21 CFR 862.1225 | 22 |
| NEO | System, Test, Osteocalcin | 第 2 类 | 21 CFR 862.1050 | 2 |
| NFX | Test, Cholesterol, Total, Over The Counter | 第 1 类 | 21 CFR 862.1175 | 1 |
| NFZ | Test, Creatinine, Over The Counter | 第 2 类 | 21 CFR 862.1225 | |
| NGA | Test, Follicle Stimulating Hormone (Fsh), Over The Counter | 第 1 类 | 21 CFR 862.1300 | 2 |
| NGD | Test, Lactic Acid, Over The Counter | 第 1 类 | 21 CFR 862.1450 | |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | 第 1 类 | 21 CFR 862.1485 | 6 |
| NGJ | Test, Nitrite, Urinary, Non-Quantitative, Over The Counter | 第 1 类 | 21 CFR 862.1510 | 1 |
| NGO | Test, Triglycerides, Over The Counter | 第 1 类 | 21 CFR 862.1705 | |
| NHG | Enzyme Immunoassay, Cortisol, Salivary | 第 2 类 | 21 CFR 862.1205 | 7 |
| NJV | Test, Albumin Cobalt Binding | 第 2 类 | 21 CFR 862.1215 | 2 |
| NQL | System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem M | 第 2 类 | 21 CFR 862.1055 | 5 |
| NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 第 1 类 | 21 CFR 862.1550 | 2 |
| NRH | System, Breath Measurement | 第 1 类 | 21 CFR 862.1820 | 4 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | 第 2 类 | 21 CFR 862.2570 | 13 |
| NVV | Digital Image, Storage And Communications, Non-Diagnostic, Laboratory | 第 1 类 | 21 CFR 862.2100 | |
| OAM | Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | 第 1 类 | 21 CFR 862.1550 | 2 |
| OHQ | Multi-Analyte Controls Unassayed | 第 1 类 | 21 CFR 862.1660 | |
| OLD | Internal Polymerase Chain Reaction Control, Not Assay Specific | 第 1 类 | 21 CFR 862.1660 | 1 |
| OND | Osmolality Of Tears | 第 1 类 | 21 CFR 862.1540 | 1 |
| OOI | Real Time Nucleic Acid Amplification System | 第 2 类 | 21 CFR 862.2570 | 14 |
| OSX | Galectin-3 In Vitro Diagnostic Assay | 第 2 类 | 21 CFR 862.1117 | 2 |
| OTA | Mass Spectrometer For Clinical Multiplex Test Systems | 第 2 类 | 21 CFR 862.2570 | |
| OUE | Micro Total Analysis Instrument System | 第 2 类 | 21 CFR 862.2570 | |
| OUL | Thermocycler, Generic | 第 1 类 | 21 CFR 862.2310 | |
| OVA | Complete Gene Expression Profiling Accessory Reagents | 第 2 类 | 21 CFR 862.2570 | 1 |
| OYG | St2 Assay | 第 2 类 | 21 CFR 862.1117 | 1 |
| OYJ | Dna Specimen Collection, Saliva | 第 2 类 | 21 CFR 862.1675 | 7 |
| PCA | Dna Genetic Analyzer | 第 2 类 | 21 CFR 862.2570 | 1 |
| PDJ | Hemoglobin A1c Test System | 第 2 类 | 21 CFR 862.1373 | 26 |
| PDS | Amniotic Fluid Protein Immunoassay | 第 1 类 | 21 CFR 862.1550 | |
| PEG | Nucleic Acid Quantitation Kit | 第 1 类 | 21 CFR 862.2310 | |
| PER | Automated Pipetting, Diluting And Specimen Processing Workstations For | 第 1 类 | 21 CFR 862.2750 | 3 |
| PFQ | Mmp-9 Test System | 第 1 类 | 21 CFR 862.1540 | 1 |
| PFT | Reagents For Molecular Diagnostic Test Systems | 第 1 类 | 21 CFR 862.3800 | 1 |
| PHG | Droplet Digital Pcr System | 第 2 类 | 21 CFR 862.2570 | |
| PHV | Continuous Glucose Monitor Retrospective Data Analysis Software | 第 1 类 | 21 CFR 862.2120 | 1 |
| PIG | Acute Kidney Injury Test System | 第 2 类 | 21 CFR 862.1220 | 5 |
| PJC | Newborn Screening Specimen Collection Paper | 第 2 类 | 21 CFR 862.1675 | 2 |
| PJD | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device | 第 2 类 | 21 CFR 862.1675 | 9 |
| PJE | Blood/Plasma Collection Device For Dna Testing | 第 2 类 | 21 CFR 862.1675 | 8 |
| PJT | Continuous Glucose Monitor Secondary Display | 第 2 类 | 21 CFR 862.1350 | 2 |
| PKU | Insulin Pump Secondary Display | 第 2 类 | 21 CFR 862.1350 | |
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | 第 2 类 | 21 CFR 862.1675 | |
| PQO | Anti-Müllerian Hormone Test System | 第 2 类 | 21 CFR 862.1092 | 5 |
| PQQ | Data Acquisition Software | 第 2 类 | 21 CFR 862.2570 | |
| PQT | Alpha-L-Iduronidase (Idua) Newborn Screening Test System | 第 2 类 | 21 CFR 862.1488 | |
| PQU | Alpha-D-Glucosidase (Gaa) Newborn Screening Test System | 第 2 类 | 21 CFR 862.1488 | |
| PQV | ß-Glucocerebrosidase (Gba) Newborn Screening Test System | 第 2 类 | 21 CFR 862.1488 | |
| PQW | Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | 第 2 类 | 21 CFR 862.1488 | 3 |
| PRJ | Capillary Blood Collection Device For Alternative Site Collection | 第 2 类 | 21 CFR 862.1675 | 2 |
| PSL | 25-Oh-Vitamin D Mass Spectrometry Test System | 第 2 类 | 21 CFR 862.1840 | 1 |
| PSM | Refractometer For Donor Testing | 第 1 类 | 21 CFR 862.2800 | |
| PTC | Uric Acid Test System For At Home Prescription Use | 第 1 类 | 21 CFR 862.1775 | 3 |
| PYP | Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test | 第 1 类 | 21 CFR 862.1475 | 1 |
| PYV | Hospital Continuous Glucose Monitoring System | 第 2 类 | 21 CFR 862.1345 | |
| PZI | Prescription Use Blood Glucose Meter For Near-Patient Testing | 第 2 类 | 21 CFR 862.1345 | 14 |
| QBJ | Integrated Continuous Glucose Monitoring System, Factory Calibrated | 第 2 类 | 21 CFR 862.1355 | 18 |
| QBV | Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentra | 第 1 类 | 21 CFR 862.2050 | 2 |
| QBZ | Automated Platform Consisting Of Software And Instrumentation For Pool | 第 1 类 | 21 CFR 862.2750 | |
| QCC | Insulin Pump Therapy Adjustment Calculator For Healthcare Professional | 第 2 类 | 21 CFR 862.1358 | 5 |
| QCL | Acid-Sphingomyelinase (Asm) Newborn Screening Test System | 第 2 类 | 21 CFR 862.1488 | |
| QCM | ß-Galactocerebrosidase (Galc) Newborn Screening Test System | 第 2 类 | 21 CFR 862.1488 | |
| QDH | Menopause Test System | 第 2 类 | 21 CFR 862.1093 | 1 |
| QDK | Integrated Continuous Glucose Monitoring System For Non-Intensive Diab | 第 2 类 | 21 CFR 862.1355 | 4 |
| QDL | Integrated Continuous Glucose Monitoring System For Professional Retro | 第 2 类 | 21 CFR 862.1355 | 1 |
| QEI | Breast Milk Macronutrients Test System | 第 2 类 | 21 CFR 862.1493 | 3 |
| QFG | Alternate Controller Enabled Insulin Infusion Pump | 第 2 类 | 21 CFR 880.5730 | 28 |
| QII | Integrated Continuous Glucose Monitoring System For Professional Direc | 第 2 类 | 21 CFR 862.1355 | 1 |
| QJE | Muscular Dystrophy Newborn Screening Test | 第 2 类 | 21 CFR 862.1506 | 1 |
| QJI | Interoperable Automated Glycemic Controller | 第 2 类 | 21 CFR 862.1356 | 22 |
| QJS | Interoperable Automated Glycemic Controller, Insulin Suspend | 第 2 类 | 21 CFR 862.1356 | 1 |
| QKE | Immunoassay, Pregnanediol Glucuronide, Over The Counter | 第 1 类 | 21 CFR 862.1620 | 1 |
| QKT | Clozapine Test System | 第 2 类 | 21 CFR 862.3245 | 1 |
| QLG | Integrated Continuous Glucose Monitoring System, Factory Calibrated, N | 第 2 类 | 21 CFR 862.1355 | 9 |
| QMA | Blood Collection Device For Cell-Free Nucleic Acid | 第 2 类 | 21 CFR 862.1676 | 2 |
| QQB | Prognostic Test For Assessment Of Liver Related Disease Progression | 第 2 类 | 21 CFR 862.1622 | 1 |
| QRV | Setmelanotide Eligibility Gene Variant Detection System | 第 2 类 | 21 CFR 862.1164 | 1 |
| QRX | Continuous Glucose Monitor Informed Insulin Dose Calculator | 第 2 类 | 21 CFR 862.1358 | 5 |
| QWH | Prognostic Test For Development Or Progression Of Preeclampsia | 第 2 类 | 21 CFR 862.1602 | 2 |
| QWZ | Prognostic Test For Assessment Of Chronic Kidney Disease Progression | 第 2 类 | 21 CFR 862.1223 | 1 |
| QZG | Menstrual Blood Collection Device | 第 2 类 | 21 CFR 862.1675 | |
| SAF | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monito | 第 2 类 | 21 CFR 862.1355 | 4 |
| SBA | Integrated Continuous Glucose Monitoring System With Sensor Containing | 第 2 类 | 21 CFR 862.1357 | 2 |
| SBH | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Manage | 第 2 类 | 21 CFR 862.1355 | 3 |
| SFO | Electrode Measurement, Drain Effluent Ph | 第 2 类 | 21 CFR 862.1120 | 1 |
| SFU | Glucose Range Monitoring System | 第 2 类 | 21 CFR 862.1359 | 1 |
| SHB | Creatinine Test System For At Home Prescription Use | 第 2 类 | 21 CFR 862.1225 | 1 |