GOM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antisera, Cf, Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA (K954515) | Pyramid Biological Corp. | 1995-12-20 |
| ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA (K953826) | Pyramid Biological Corp. | 1995-12-14 |
Track GOM automatically
Every clearance here is in the API, with alerts when new ones post.