Bedford, MA, US · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GGW | Test, Time, Partial Thromboplastin | Class II | Hematology | 1 | 2026-03-20 |
| GFO | Activated Partial Thromboplastin | Class II | Hematology | 1 | 2026-01-09 |
| KQJ | System, Fibrinogen Determination | Class II | Hematology | 1 | 2025-07-24 |
| LCO | Platelet Factor 4 Radioimmunoassay | Class II | Hematology | 1 | 2025-01-28 |
| GKP | — | — | — | 1 | 2024-08-16 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-20 | K260551 | HemosIL Factor V Leiden (APC Resistance V) | GGW | Class II | Hematology |
| 2026-01-09 | K253957 | HemosIL Silica Clotting Time | GFO | Class II | Hematology |
| 2025-07-24 | K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | KQJ | Class II | Hematology |
| 2025-01-28 | K243374 | HemosIL CL HIT-IgG(PF4-H) | LCO | Class II | Hematology |
| 2024-08-16 | K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) | GKP | — | — |