Hangzhou, CN · 13 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NFT | Test, Amphetamine, Over The Counter | Class II | Clinical Toxicology | 4 | 2025-04-04 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Class II | Clinical Chemistry | 2 | 2025-07-15 |
| GTY | Antigens, All Groups, Streptococcus Spp. | Class I | Microbiology | 1 | 2026-04-30 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Class I | Clinical Chemistry | 1 | 2025-10-30 |
| JSM | Culture Media, Non-Propagating Transport | Class I | Microbiology | 1 | 2025-04-04 |
| DKZ | Enzyme Immunoassay, Amphetamine | Class II | Clinical Toxicology | 1 | 2023-12-13 |
| NGL | Test, Opiates, Over The Counter | Class II | Clinical Toxicology | 1 | 2023-10-26 |
| DJG | Enzyme Immunoassay, Opiates | Class II | Clinical Toxicology | 1 | 2023-07-31 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | Class II | Clinical Chemistry | 1 | 2022-01-31 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-30 | K260342 | AllTest Strep A Rapid Test | GTY | Class I | Microbiology |
| 2025-10-30 | K252607 | AllTest Urinary Tract Infection Test | JMT | Class I | Clinical Chemistry |
| 2025-07-15 | K251053 | Shinetell PlusTM Digital Early Pregnancy Test | LCX | Class II | Clinical Chemistry |
| 2025-04-04 | K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | NFT | Class II | Clinical Toxicology |
| 2025-04-04 | K242576 | AllTest Viral Transport Medium | JSM | Class I | Microbiology |
| 2025-02-27 | K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | NFT | Class II | Clinical Toxicology |
| 2024-09-27 | K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | NFT | Class II | Clinical Toxicology |
| 2024-08-13 | K241978 | Shinetell Digital Pregnancy Test | LCX | Class II | Clinical Chemistry |
| 2024-06-17 | K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | NFT | Class II | Clinical Toxicology |
| 2023-12-13 | K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx | DKZ | Class II | Clinical Toxicology |
| 2023-10-26 | K233417 | AllTest Fentanyl Urine Test Cassette | NGL | Class II | Clinical Toxicology |
| 2023-07-31 | K231698 | AllTest Fentanyl Rapid Test (Urine) | DJG | Class II | Clinical Toxicology |
| 2022-01-31 | K203272 | Alltest Pregnancy Rapid Combo Test Cassette | JHI | Class II | Clinical Chemistry |