DAF
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Gamma Globulin, Fitc, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2008: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PRECINORM(R) PROTEIN (K871027) | Boehringer Mannheim Corp. | 1987-05-15 |
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Every clearance here is in the API, with alerts when new ones post.