MIF
6 FDA 510(k) clearances · Product code
135 daysmedian time to decision
212 days90th percentile
6clearances measured
FDA profile
- Official device name
- Prothrombin Fragment 1.2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7320
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ENZYGNOST F+2 (MONOCLONAL) TEST KIT (K042687) | Dade Behring, Inc. | 2004-12-10 |
| THROMBONOSTIKA F1.2 (K964934) | Organon Teknika Corp. | 1997-03-18 |
| TPP (K962176) | Panbio, Inc. | 1996-10-18 |
| ENZYGNOST F 1+2 (K922934) | Behring Diagnostics, Inc. | 1992-11-16 |
| DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA (K920895) | Baxter Diagnostics, Inc. | 1992-06-04 |
| THROMBONOSTIKA F1.2 (K911434) | Organon Teknika Corp. | 1991-10-31 |
Track MIF automatically
Every clearance here is in the API, with alerts when new ones post.