San Diego, CA, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| CIX | Bromcresol Green Dye-Binding, Albumin | Class II | Clinical Chemistry | 1 | 2026-01-09 |
| CHH | — | — | — | 1 | 2025-12-30 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | Class II | Clinical Chemistry | 1 | 2025-12-19 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | Class II | Clinical Chemistry | 1 | 2025-11-26 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-09 | K251157 | Core Metabolic | CIX | Class II | Clinical Chemistry |
| 2025-12-30 | K251091 | Lipids | CHH | — | — |
| 2025-12-19 | K251074 | Tru Liver Health Test Panel | CJE | Class II | Clinical Chemistry |
| 2025-11-26 | K251058 | Tru Kidney Health Test Panel; Tru Analyzer | CGX | Class II | Clinical Chemistry |