Hangzhou, CN · 3 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DJC | Thin Layer Chromatography, Methamphetamine | Class II | Clinical Toxicology | 1 | 2025-03-18 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Class II | Clinical Toxicology | 1 | 2024-01-10 |
| DJG | Enzyme Immunoassay, Opiates | Class II | Clinical Toxicology | 1 | 2024-01-09 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-03-18 | K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | DJC | Class II | Clinical Toxicology |
| 2024-01-10 | K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) | LDJ | Class II | Clinical Toxicology |
| 2024-01-09 | K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) | DJG | Class II | Clinical Toxicology |