Hangzhou, CN · 3 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | Class I | Microbiology | 1 | 2026-01-30 |
| NFT | Test, Amphetamine, Over The Counter | Class II | Clinical Toxicology | 1 | 2025-08-27 |
| NGL | Test, Opiates, Over The Counter | Class II | Clinical Toxicology | 1 | 2024-11-08 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-30 | K253318 | Clungene RSV Antigen Rapid Test | GQG | Class I | Microbiology |
| 2025-08-27 | K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup | NFT | Class II | Clinical Toxicology |
| 2024-11-08 | K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | NGL | Class II | Clinical Toxicology |