GFX
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fibrinogen Standard
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7340
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FIBRINOGEN CALIBRATOR KIT (K072304) | Dade Behring, Inc. | 2007-09-19 |
| FIBRINOGEN CALIBRATOR KIT (K994341) | Dade Behring, Inc. | 2000-03-03 |
| ACA FIBRINOGEN CALIBRATOR (K812628) | E.I. Dupont DE Nemours & Co., Inc. | 1981-11-24 |
Track GFX automatically
Every clearance here is in the API, with alerts when new ones post.