DDF
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prothrombin, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5735
- Medical specialty
- Immunology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NATIVE PROTHROMBIN ANTIGEN EIA (K910617) | Organon Teknika Corp. | 1991-05-15 |
| AGGLUTEX MORPHINE TEST KIT (K812985) | Hoffmann-La Roche, Inc. | 1981-12-31 |
Track DDF automatically
Every clearance here is in the API, with alerts when new ones post.