| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| LET | Fluorescent Immunoassay, Phenobarbital | 第 2 类 | 21 CFR 862.3660 | 8 |
| LEW | Thin Layer Chromatography, Theophylline | 第 2 类 | 21 CFR 862.3880 | 1 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 第 2 类 | 21 CFR 862.3910 | 21 |
| LFH | U.V. Spectrometry, Tricyclic Antidepressant Drugs | 第 2 类 | 21 CFR 862.3910 | 6 |
| LFI | High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs | 第 2 类 | 21 CFR 862.3910 | 4 |
| LFM | Enzyme Immunoassay, Digitoxin | 第 2 类 | 21 CFR 862.3300 | 20 |
| LFN | Nephelometric Inhibition Immunoassay, Phenobarbital | 第 2 类 | 21 CFR 862.3660 | 5 |
| LFO | Nephelometric Inhibition Immunoassay, Diphenylhydantoin | 第 2 类 | 21 CFR 862.3350 | 1 |
| LFT | Fluorescent Immunoassay, Primidone | 第 2 类 | 21 CFR 862.3680 | 8 |
| LFW | Fluorescence Polarization Immunoassay, Tobramycin | 第 2 类 | 21 CFR 862.3900 | 10 |
| LGI | Fluorescence Polarization Immunoassay, Carbamazepine | 第 2 类 | 21 CFR 862.3645 | 3 |
| LGJ | Fluorescence Polarization Immunoassay, Amibacin | 第 2 类 | 21 CFR 862.3035 | 3 |
| LGQ | Fluorescence Polarization Immunoassay, Phenobarbital | 第 2 类 | 21 CFR 862.3660 | 12 |
| LGR | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) | 第 2 类 | 21 CFR 862.3350 | 15 |
| LGS | Fluorescence Polarization Immunoassay, Theophylline | 第 2 类 | 21 CFR 862.3880 | 13 |
| LPX | Radioceptor Assay, Neuroleptic Drugs | 第 2 类 | 21 CFR 862.3645 | |
| MKU | Enzyme Immunoassay, Nicotine And Nicotine Metabolites | 第 1 类 | 21 CFR 862.3220 | 7 |
| MLK | Thin Layer Chromatography, Tricyclic Antidepressant Drugs | 第 2 类 | 21 CFR 862.3910 | 2 |
| MOJ | Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free) | 第 2 类 | 21 CFR 862.3350 | 3 |
| MRS | Test System, Nicotine, Cotinine, Metabolites | 第 1 类 | 21 CFR 862.3220 | 3 |
| MSL | System, Test, Topiramatee | 第 2 类 | 21 CFR 862.3350 | 1 |
| MXA | System, Test, Breath Nitric Oxide | 第 2 类 | 21 CFR 862.3080 | 15 |
| NDW | Assay, Porphyrin, Spectrophotometry, Lithium | 第 2 类 | 21 CFR 862.3560 | 7 |
| NFT | Test, Amphetamine, Over The Counter | 第 2 类 | 21 CFR 862.3100 | 31 |
| NFV | Test, Benzodiazepine, Over The Counter | 第 2 类 | 21 CFR 862.3170 | |
| NFW | Test, Cannabinoid, Over The Counter | 第 2 类 | 21 CFR 862.3870 | 4 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | 第 2 类 | 21 CFR 862.3250 | |
| NGG | Test, Methamphetamine, Over The Counter | 第 2 类 | 21 CFR 862.3610 | 1 |
| NGI | Test, Morphine, Over The Counter | 第 2 类 | 21 CFR 862.3640 | |
| NGL | Test, Opiates, Over The Counter | 第 2 类 | 21 CFR 862.3650 | 23 |
| NRP | Sirolimus Test System | 第 2 类 | 21 CFR 862.3840 | 5 |
| NTI | Drug Metabolizing Enzyme Genotyping Systems | 第 2 类 | 21 CFR 862.3360 | 11 |
| NVI | Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease | 第 2 类 | 21 CFR 862.3100 | 1 |
| NWM | Immunoassay, Anti-Seizure Drug | 第 2 类 | 21 CFR 862.3350 | 5 |
| OAV | Mycophenolic Acid Test System | 第 2 类 | 21 CFR 862.3840 | 3 |
| ODW | Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping S | 第 2 类 | 21 CFR 862.3360 | 6 |
| OIC | Blood Alcohol Kit (Excludes Hiv Testing) | 第 2 类 | 21 CFR 862.3040 | |
| OIW | Software, Similarity Score Algorithm, Tissue Of Origin For Malignant T | 第 2 类 | 21 CFR 862.3100 | 4 |
| ORA | Breast Milk-Alcohol Test System | 第 2 类 | 21 CFR 862.3040 | |
| ORH | Lamotrigine Assay | 第 2 类 | 21 CFR 862.3350 | 2 |
| ORI | Levetiracetam Assay | 第 2 类 | 21 CFR 862.3350 | 2 |
| OTF | Gabapentin Assay | 第 2 类 | 21 CFR 862.3350 | 1 |
| OUF | Everolimus Immunoassay | 第 2 类 | 21 CFR 862.3840 | 2 |
| PDY | Organophosphate Test System | 第 2 类 | 21 CFR 862.3652 | 1 |
| POX | Enzyme Immunoassay, Oxcarbazepine Metabolite | 第 2 类 | 21 CFR 862.3645 | 1 |
| PTG | Test, Methadone, Over The Counter | 第 2 类 | 21 CFR 862.3620 | |
| PTH | Test, Barbiturate, Over The Counter | 第 2 类 | 21 CFR 862.3150 | 1 |
| PUJ | Voriconazole Test System | 第 2 类 | 21 CFR 862.3970 | 1 |
| PUX | Test, Amphetamine, Employment And Insurance Testing, Exempt | 第 2 类 | 21 CFR 862.3100 | |
| PUY | Test, Barbiturate, Employment And Insurance Testing, Exempt | 第 2 类 | 21 CFR 862.3150 | |
| PUZ | Test, Benzodiazepine, Employment And Insurance Testing, Exempt | 第 2 类 | 21 CFR 862.3170 | |
| PVA | Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing | 第 2 类 | 21 CFR 862.3250 | |
| PVB | Test, Codeine, Employment And Insurance Testing, Exempt | 第 2 类 | 21 CFR 862.3270 | |
| PVC | Test, Lsd, Employment And Insurance Testing, Exempt | 第 2 类 | 21 CFR 862.3580 | |
| PVD | Test, Methamphetamine, Employment And Insurance Testing, Exempt | 第 2 类 | 21 CFR 862.3610 | |
| PVE | Test, Methadone, Employment And Insurance Testing, Exempt | 第 2 类 | 21 CFR 862.3620 | |
| PVF | Test, Methaqualone, Employment And Insurance Testing, Exempt | 第 2 类 | 21 CFR 862.3630 | |
| PVG | Test, Morphine, Employment And Insurance Testing, Exempt | 第 2 类 | 21 CFR 862.3640 | |
| PVH | Test, Opiates, Employment And Insurance Testing, Exempt | 第 2 类 | 21 CFR 862.3650 | |
| PVI | Test, Propoxyphene, Employment And Insurance Testing, Exempt | 第 2 类 | 21 CFR 862.3700 | |
| PVJ | Test, Cannabinoid, Employment And Insurance Testing, Exempt | 第 2 类 | 21 CFR 862.3870 | |
| PVK | Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing | 第 2 类 | 21 CFR 862.3910 | |
| QAW | Test, Tricyclic Antidepressants, Over The Counter | 第 2 类 | 21 CFR 862.3910 | |
| QBF | Test, Propoxyphene, Over The Counter | 第 2 类 | 21 CFR 862.3700 | 1 |
| QBK | Meprobamate Test System | 第 2 类 | 21 CFR 862.3590 | 2 |
| QDR | Plazomicin Test System, Immunoassay | 第 2 类 | 21 CFR 862.3460 | 1 |
| QXT | Infliximab Test System | 第 2 类 | 21 CFR 862.3115 | 1 |
| QYD | Adalimumab Assay | 第 2 类 | 21 CFR 862.3115 | 1 |