DEP
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Lambda, 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 |
|---|---|---|
| J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. (K801662) | J.T. Baker Chemical Co. | 1980-09-16 |
Track DEP automatically
Every clearance here is in the API, with alerts when new ones post.