Dundee, GB · 3 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NBC | Test, Natriuretic Peptide | Class II | Clinical Chemistry | 2 | 2026-02-18 |
| CDD | Radioassay, Vitamin B12 | Class II | Clinical Chemistry | 1 | 2024-07-31 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-02-18 | K253539 | Alere NT-proBNP for Alinity i | NBC | Class II | Clinical Chemistry |
| 2025-01-16 | K241176 | Alere NT-proBNP for Alinity i Reagent Kit | NBC | Class II | Clinical Chemistry |
| 2024-07-31 | K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | CDD | Class II | Clinical Chemistry |