DAN
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fibrinopeptide A, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5350
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RIA/MAT FPA TEST KIT (K884496) | Altana, Inc. | 1988-11-16 |
| ASSERACHROM FPA KIT (K854384) | American Bioproducts Co. | 1986-02-04 |
| RIA-QUANT FPA TEST KIT (K821151) | Mallinckrodt Critical Care | 1982-07-22 |
Track DAN automatically
Every clearance here is in the API, with alerts when new ones post.