Hangzhou, CN · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NFT | Test, Amphetamine, Over The Counter | Class II | Clinical Toxicology | 2 | 2021-03-24 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Class I | Clinical Chemistry | 1 | 2025-01-10 |
| NGL | Test, Opiates, Over The Counter | Class II | Clinical Toxicology | 1 | 2024-04-10 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Class II | Clinical Chemistry | 1 | 2020-08-13 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-01-10 | K242767 | Safecare Urinary Tract Infection Test | JMT | Class I | Clinical Chemistry |
| 2024-04-10 | K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | NGL | Class II | Clinical Toxicology |
| 2021-03-24 | K202453 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | NFT | Class II | Clinical Toxicology |
| 2020-08-13 | K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream | LCX | Class II | Clinical Chemistry |
| 2020-05-27 | K201120 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | NFT | Class II | Clinical Toxicology |