DFD
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Kappa, Peroxidase, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- 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 |
|---|---|---|
| VENTANA CEA PRIMARY ANTIBODY (K940242) | Ventana Medical Systems, Inc. | 1996-12-23 |
| PSA ANTIBODY KIT (K924578) | Ventana Medical Systems, Inc. | 1993-02-05 |
| PAP ANTIBODY KIT (K924629) | Ventana Medical Systems, Inc. | 1993-02-04 |
Track DFD automatically
Every clearance here is in the API, with alerts when new ones post.