| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| JPC | Hemoglobin F Quantitation | 第 2 类 | 21 CFR 864.7455 | 1 |
| JPD | Hemoglobin A2 Quantitation | 第 2 类 | 21 CFR 864.7400 | 13 |
| JPE | Antithrombin Iii, Two Stage Clotting Time Assay | 第 2 类 | 21 CFR 864.7060 | 1 |
| JPF | Prothrombin-Proconvertin And Thrombotest | 第 2 类 | 21 CFR 864.7735 | |
| JPH | Test, Erythrocyte Sedimentation Rate | 第 1 类 | 21 CFR 864.6700 | 7 |
| JPI | Device, Hematocrit Measuring | 第 2 类 | 21 CFR 864.6400 | 15 |
| JPJ | Red-Cell Indices, Calculated | 第 2 类 | 21 CFR 864.5300 | 3 |
| JPK | Mixture, Hematology Quality Control | 第 2 类 | 21 CFR 864.8625 | 192 |
| JTS | Stains, Microbiologic | 第 1 类 | 21 CFR 864.1850 | 40 |
| JWO | Device, Blood Volume Measuring | 第 2 类 | 21 CFR 864.5950 | 3 |
| JWR | Atp Release (Luminescence) | 第 1 类 | 21 CFR 864.7040 | |
| KFC | Methylene Blue, Tissue Stain | 第 1 类 | 21 CFR 864.1850 | 7 |
| KFD | Aniline Blue | 第 1 类 | 21 CFR 864.1850 | 1 |
| KFE | Neutral Red | 第 1 类 | 21 CFR 864.1850 | 1 |
| KFF | Assay, Heparin | 第 2 类 | 21 CFR 864.7525 | 46 |
| KHE | Reagent, Occult Blood | 第 2 类 | 21 CFR 864.6550 | 97 |
| KHF | Adenine Nucleotide Quantitation | 第 1 类 | 21 CFR 864.7040 | |
| KHG | Whole Blood Hemoglobin Determination | 第 2 类 | 21 CFR 864.7500 | 39 |
| KIP | Formulations, Balanced Salt Solutions | 第 1 类 | 21 CFR 864.2875 | 17 |
| KIQ | Kit, Culture, Chromosome | 第 1 类 | 21 CFR 864.2260 | 1 |
| KIR | Cells, Animal And Human, Cultured | 第 1 类 | 21 CFR 864.2280 | 170 |
| KIS | Sera, Animal And Human | 第 1 类 | 21 CFR 864.2800 | 45 |
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 第 1 类 | 21 CFR 864.2220 | 367 |
| KIW | Kit, Mycoplasma Detection | 第 1 类 | 21 CFR 864.2360 | 2 |
| KIX | Media, Mycoplasma Detection | 第 1 类 | 21 CFR 864.2360 | |
| KIY | Chamber, Slide Culture | 第 1 类 | 21 CFR 864.2240 | 1 |
| KIZ | Dish, Tissue Culture | 第 1 类 | 21 CFR 864.2240 | 8 |
| KJA | Flask, Tissue Culture | 第 1 类 | 21 CFR 864.2240 | 13 |
| KJB | Apparatus, Roller | 第 1 类 | 21 CFR 864.2240 | 3 |
| KJC | Bottle, Roller, Tissue Culture | 第 1 类 | 21 CFR 864.2240 | 3 |
| KJD | Spinner, Flask | 第 1 类 | 21 CFR 864.2240 | |
| KJE | Spinner System, Cell Culture | 第 1 类 | 21 CFR 864.2240 | |
| KJF | System, Suspension, Cell Culture | 第 1 类 | 21 CFR 864.2240 | 4 |
| KJH | Apparatus, Perfusion | 第 1 类 | 21 CFR 864.2240 | 3 |
| KJK | Auramine O | 第 1 类 | 21 CFR 864.1850 | 2 |
| KJL | Azure C | 第 1 类 | 21 CFR 864.1850 | |
| KJM | Bismarck Brown Y | 第 1 类 | 21 CFR 864.1850 | |
| KJN | Brilliant Cresyl Blue | 第 1 类 | 21 CFR 864.1850 | 1 |
| KJO | Brilliant Green | 第 1 类 | 21 CFR 864.1850 | |
| KJP | Carmine | 第 1 类 | 21 CFR 864.1850 | |
| KJQ | Chlorazol Black E | 第 1 类 | 21 CFR 864.1850 | |
| KJR | Erythrosin B | 第 1 类 | 21 CFR 864.1850 | 3 |
| KJS | Ethyl Eosin | 第 1 类 | 21 CFR 864.1850 | |
| KJT | Indigocarmine | 第 1 类 | 21 CFR 864.1850 | |
| KJW | Janus Green B | 第 1 类 | 21 CFR 864.1850 | |
| KJX | Jenner Stain | 第 1 类 | 21 CFR 864.1850 | 1 |
| KJY | Malachite Green | 第 1 类 | 21 CFR 864.1850 | 1 |
| KJZ | Martius Yellow | 第 1 类 | 21 CFR 864.1850 | |
| KKA | Methyl Orange | 第 1 类 | 21 CFR 864.1850 | |
| KKB | Methyl Violet 2b | 第 1 类 | 21 CFR 864.1850 | |
| KKC | Methylene Violet | 第 1 类 | 21 CFR 864.1850 | |
| KKD | Nigrosin | 第 1 类 | 21 CFR 864.1850 | |
| KKE | Orange Ii | 第 1 类 | 21 CFR 864.1850 | |
| KKF | Orcein | 第 1 类 | 21 CFR 864.1850 | |
| KKG | Protargol S | 第 1 类 | 21 CFR 864.1850 | |
| KKH | Tablet, Resazurin | 第 1 类 | 21 CFR 864.1850 | |
| KKI | Rose Bengal | 第 1 类 | 21 CFR 864.1850 | |
| KKJ | Sudan Iii | 第 1 类 | 21 CFR 864.1850 | 1 |
| KKK | Sudan Iv | 第 1 类 | 21 CFR 864.1850 | 1 |
| KKL | Thionin | 第 1 类 | 21 CFR 864.1850 | |
| KKM | Methylene Blue Thiocyanate | 第 1 类 | 21 CFR 864.1850 | |
| KKP | Solution, Silver Carbonate | 第 1 类 | 21 CFR 864.1850 | |
| KKQ | Sodium Periodate | 第 1 类 | 21 CFR 864.1850 | |
| KKR | Potassium Periodate | 第 1 类 | 21 CFR 864.1850 | |
| KKS | Acid, Periodic | 第 1 类 | 21 CFR 864.1850 | |
| KKT | Hematoxylin, Ehrlich'S | 第 1 类 | 21 CFR 864.1850 | |
| KKW | Basic Fuchsin | 第 1 类 | 21 CFR 864.1850 | |
| KPB | Media And Components, Mycoplasma Detection | 第 1 类 | 21 CFR 864.2360 | 4 |
| KQC | Stains, Hematology | 第 1 类 | 21 CFR 864.1850 | 9 |
| KQE | Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase | 第 2 类 | 21 CFR 864.7360 | 1 |
| KQF | Assay, Glutathione Reductase | 第 2 类 | 21 CFR 864.7375 | |
| KQG | Instrument, Coagulation | 第 2 类 | 21 CFR 864.5400 | 14 |
| KQH | Red-Cell Indices | 第 2 类 | 21 CFR 864.5300 | 1 |
| KQI | Assay, Fetal Hemoglobin | 第 2 类 | 21 CFR 864.7455 | 4 |
| KQJ | System, Fibrinogen Determination | 第 2 类 | 21 CFR 864.7340 | 28 |
| KRX | Calibrator For Cell Indices | 第 2 类 | 21 CFR 864.8150 | 16 |
| KRY | Calibrator For Platelet Counting | 第 2 类 | 21 CFR 864.8175 | 8 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 第 2 类 | 21 CFR 864.8165 | 25 |
| KSA | Calibrator For Red-Cell And White-Cell Counting | 第 2 类 | 21 CFR 864.8185 | 8 |
| KSB | Set, Transfer (Blood/Plasma) | 第 2 类 | 21 CFR 864.9875 | 6 |
| KSD | Device, Heat-Sealing | 第 1 类 | 21 CFR 864.9750 | 1 |
| KSE | Refrigerator, Freezer, Blood Storage | 第 2 类 | 21 CFR 864.9700 | 4 |
| KSF | Kit, Quality Control For Blood Banking Reagents | 第 2 类 | 21 CFR 864.9650 | 12 |
| KSG | Media, Potentiating For In Vitro Diagnostic Use | 第 2 类 | 21 CFR 864.9600 | 13 |
| KSH | Chamber, Environmental For The Storage Of Platelet Concentrate | 第 2 类 | 21 CFR 864.9575 | |
| KSI | Lectins And Protectins | 第 2 类 | 21 CFR 864.9550 | 4 |
| KSK | Solution, Stabilized Enzyme | 第 2 类 | 21 CFR 864.9400 | 5 |
| KSL | Solution, Copper Sulfate For Specific Gravity Determinations | 第 1 类 | 21 CFR 864.9320 | 2 |
| KSM | System, Test, Combs, Automated | 第 2 类 | 21 CFR 864.9300 | |
| KSN | Centrifuge, Cell-Washing, Automated For Immuno-Hematology | 第 2 类 | 21 CFR 864.9285 | 1 |
| KSO | Centrifuge, Blood-Bank For In Vitro Diagnostic Use | 第 1 类 | 21 CFR 864.9275 | 1 |
| KSP | Apparatus, Cell-Freezing And Reagents | 第 1 类 | 21 CFR 864.9225 | 1 |
| KSQ | Device, Blood Mixing And Blood Weighing | 第 1 类 | 21 CFR 864.9195 | 8 |
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Compone | 第 2 类 | 21 CFR 864.9100 | 16 |
| KSS | Supplies, Blood-Bank | 第 1 类 | 21 CFR 864.9050 | 6 |
| KST | System, Blood Collection, Vacuum-Assisted, Manual | 第 1 类 | 21 CFR 864.9125 | |
| KSW | System, Processing For Frozen Blood | 第 2 类 | 21 CFR 864.9145 | 1 |
| KSX | Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic | 第 2 类 | 21 CFR 864.9160 | 8 |
| KSY | Boxes, View, Blood Grouping | 第 1 类 | 21 CFR 864.9185 | 1 |
| KSZ | System, Test, Automated Blood Grouping And Antibody | 第 2 类 | 21 CFR 864.9175 | 4 |
| KZL | Device, Warming. Blood And Plasma | 第 2 类 | 21 CFR 864.9205 | 4 |
| LCO | Platelet Factor 4 Radioimmunoassay | 第 2 类 | 21 CFR 864.7695 | 13 |
| LCP | Assay, Glycosylated Hemoglobin | 第 2 类 | 21 CFR 864.7470 | 249 |
| LED | Stains, Chemical Solution | 第 1 类 | 21 CFR 864.1850 | 16 |
| LEE | Stains, Dye Solution | 第 1 类 | 21 CFR 864.1850 | 1 |
| LEF | Stains, Dye Powder | 第 1 类 | 21 CFR 864.1850 | 1 |
| LGL | Assay, Bart'S, Hemoglobin | 第 2 类 | 21 CFR 864.7500 | 2 |
| LGO | Test, Leukocyte Typing | 第 1 类 | 21 CFR 864.7675 | 5 |
| LGP | Assay, Alpha-2-Antiplasmin | 第 2 类 | 21 CFR 864.5425 | 5 |
| LGY | Trypan Blue | 第 1 类 | 21 CFR 864.1850 | 1 |
| LIM | Test, Screening, For D Positive Fetal Rbc'S | 第 2 类 | 21 CFR 864.7455 | 2 |
| LIZ | Assay, T Lymphocyte Surface Marker | 第 2 类 | 21 CFR 864.5220 | 7 |
| LJD | Assay, B Lymphocyte Marker | 第 2 类 | 21 CFR 864.5220 | 1 |
| LJX | Test, Urine Leukocyte | 第 1 类 | 21 CFR 864.7675 | 7 |
| LKM | Counter, Urine Particle | 第 2 类 | 21 CFR 864.5200 | 15 |
| LKZ | Red-Cell Count By Photometry | 第 2 类 | 21 CFR 864.7100 | 2 |
| LLG | Kit, Igg, Platelet Associated | 第 2 类 | 21 CFR 864.5425 | 2 |
| LNJ | Analyzer, Chromosome, Automated | 第 2 类 | 21 CFR 864.5260 | 11 |
| LPI | Kit, Assay, Progesterone Receptor | 第 3 类 | 21 CFR 864.1860 | |
| LPJ | Kit, Assay, Estrogen Receptor | 第 3 类 | 21 CFR 864.1860 | |
| MAM | Dna-Probe, B And T Lymphocyte | 第 2 类 | 21 CFR 864.5220 | 1 |
| MIF | Prothrombin Fragment 1.2 | 第 2 类 | 21 CFR 864.7320 | 6 |
| MLL | Hemoglobin C (Abnormal Hemoglobin Variant) | 第 2 类 | 21 CFR 864.7415 | 1 |
| MMH | Blood Establishment Computer Software And Accessories | 第 2 类 | 21 CFR 864.9165 | |
| MXZ | Immunohistochemistry Assay, Antibody, Progesterone Receptor | 第 2 类 | 21 CFR 864.1860 | 13 |
| MYA | Immunohistochemistry Antibody Assay, Estrogen Receptor | 第 2 类 | 21 CFR 864.1860 | 12 |
| MYJ | Device, Mixing And Weighing, Semi-Automated | 第 2 类 | 21 CFR 864.9195 | |
| MYX | System, Blood Collection, Vacuum-Assisted, Automated | 第 1 类 | 21 CFR 864.9125 | |
| MZG | Test, Residual, Wbc In Leukoreduced Blood | 第 2 类 | 21 CFR 864.8625 | |
| NBK | System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer | 第 2 类 | 21 CFR 864.1860 | 1 |
| NGB | Test, Glycosylated Hemoglobin, Over The Counter | 第 2 类 | 21 CFR 864.7470 | |
| NGK | Test, Occult Blood, Over The Counter | 第 2 类 | 21 CFR 864.6550 | |
| NID | Assay, Proliferation, In Vitro, T Lymphocyte | 第 2 类 | 21 CFR 864.5220 | 2 |
| NJT | Immunohistochemistry Reagents And Kits | 第 1 类 | 21 CFR 864.1860 | |
| NJW | Control Material, Her-2/Neu, Immunohistochemistry | 第 2 类 | 21 CFR 864.1860 | 2 |
| NKF | Immunohistochemistry Antibody Assay, C-Kit | 第 3 类 | 21 CFR 864.1860 | |
| NOT | Microscope, Automated, Image Analysis, Operator Intervention | 第 2 类 | 21 CFR 864.1860 | 13 |
| NOZ | Assay, 1,5-Anhydroglucitol (15ag) | 第 2 类 | 21 CFR 864.7470 | 2 |
| NPQ | Test, Factor V Leiden Mutations, Genomic Dna Pcr | 第 2 类 | 21 CFR 864.7280 | 6 |
| NPR | Test, Factor Ii G20210a Mutations, Genomic Dna Pcr | 第 2 类 | 21 CFR 864.7280 | 5 |
| NQF | Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor | 第 3 类 | 21 CFR 864.1860 | |
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator I | 第 2 类 | 21 CFR 864.1860 | 15 |
| NRF | Material, Quality Control, Semen Analysis | 第 2 类 | 21 CFR 864.8625 | 3 |
| NRS | Control Material, Blood Circulating Epithelial Cancer Cell | 第 2 类 | 21 CFR 864.8625 | 1 |
| NTR | Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P6 | 第 1 类 | 21 CFR 864.1860 | 1 |
| NVG | Tissue Culture, Accessories, Dental | 第 1 类 | 21 CFR 864.2240 | |
| OAO | Cord Blood Processing System And Storage Container | 第 2 类 | 21 CFR 864.9900 | |
| OBW | 11-Dehydro Thromboxane B2 Kit, Urinary | 第 2 类 | 21 CFR 864.5700 | 1 |
| ODV | Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping Sy | 第 2 类 | 21 CFR 864.7750 | 1 |
| OEO | Automated Digital Image Manual Interpretation Microscope | 第 2 类 | 21 CFR 864.1860 | 6 |
| OMM | Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna | 第 2 类 | 21 CFR 864.7280 | 2 |
| OOF | Cryogenic Cord Blood Storage Container | 第 2 类 | 21 CFR 864.9900 | |
| OOX | Automated Occult Blood Analyzer | 第 2 类 | 21 CFR 864.6550 | 6 |
| OQX | Self-Contained Blood Grouping | 第 2 类 | 21 CFR 864.9175 | |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | 第 2 类 | 21 CFR 864.9245 | |
| OSL | Control, Fecal Occult Blood | 第 2 类 | 21 CFR 864.6550 | 1 |
| OYE | Flow Cytometric Reagents And Accessories. | 第 2 类 | 21 CFR 864.5220 | 8 |
| PBC | Manual Blood Grouping And Antibody Test Systems | 第 2 类 | 21 CFR 864.9175 | |
| PDO | Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Charac | 第 2 类 | 21 CFR 864.1870 | 1 |
| PDX | Flow Cytometry Calibrator | 第 2 类 | 21 CFR 864.5220 | |
| PFG | Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, He | 第 2 类 | 21 CFR 864.1870 | 1 |
| PFK | Quality Control For Molecular Immunohematology Tests | 第 2 类 | 21 CFR 864.9650 | |
| PHJ | System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophi | 第 2 类 | 21 CFR 864.7280 | 1 |
| PKG | Bone Marrow Processing Device To Support Hematopoietic Reconstitution | 第 2 类 | 21 CFR 864.9245 | |
| PMG | Automated Multicolor Fluorescent Imaging Cytometric Analysis System | 第 2 类 | 21 CFR 864.5220 | 1 |
| PMQ | Peripheral Blood Processing Device For Wound Management | 第 2 类 | 21 CFR 864.9245 | |
| POV | Semen Analysis Device | 第 2 类 | 21 CFR 864.5220 | 28 |
| PWD | Flow Cytometric Test System For Hematopoietic Neoplasms | 第 2 类 | 21 CFR 864.7010 | 2 |
| QFR | Coagulation System For The Measurement Of Whole Blood Viscoelastic Pro | 第 2 类 | 21 CFR 864.5430 | 8 |
| QGU | Hemoglobin For Donor Testing | 第 2 类 | 21 CFR 864.7500 | |
| QHR | Blood Grouping Reagent | 第 U 类 | 21 CFR 660.20 | |
| QHS | Anti-Human Globulin | 第 U 类 | 21 CFR 660.50 | |
| QHT | Reagent Red Blood Cells | 第 U 类 | 21 CFR 660.30 | |
| QKF | Immunocytochemistry Assay, P16/Ki-67 | 第 3 类 | 21 CFR 864.1860 | |
| QLU | Anti-Factor Xa Activity Test System, Apixaban | 第 2 类 | 21 CFR 864.7295 | 3 |
| QNH | Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay | 第 3 类 | 21 CFR 864.1860 | |
| QTY | Von Willebrand Factor Assay | 第 2 类 | 21 CFR 864.7293 | 1 |
| QUL | Immunohistochemistry Assay, Antibody, Folr1 | 第 3 类 | 21 CFR 864.1860 | |
| QYC | Container System For The Processing And Storage Of Red Blood Cell Comp | 第 2 类 | 21 CFR 864.9115 | |
| QZJ | Immunohistochemistry Assay, Antibody, Claudin 18 | 第 3 类 | 21 CFR 864.1860 | |
| SAC | Adamts13 Activity Test System | 第 2 类 | 21 CFR 864.7297 | 1 |
| SAL | Device, Automated Cell Locating, Bone Marrow | 第 2 类 | 21 CFR 864.5261 | 1 |
| SBL | Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4 | 第 3 类 | 21 CFR 864.1860 | |
| SDP | Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna | 第 2 类 | 21 CFR 864.1861 | 1 |
| SER | Immunohistochemistry Assay, Antibody, Met | 第 3 类 | 21 CFR 864.1860 | |
| SES | Non-Factor Replacement Product Test System | 第 2 类 | 21 CFR 864.7298 | 1 |
| SFS | Revumenib Eligibility Detection System | 第 2 类 | 21 CFR 864.1885 | 1 |