DAT
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7340
- 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 |
|---|---|---|
| FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM (K924892) | Organon Teknika Corp. | 1994-04-21 |
| SPECTRASCAN (K781103) | Medishield, Inc. | 1978-09-27 |
Track DAT automatically
Every clearance here is in the API, with alerts when new ones post.