DEF
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5425
- Medical specialty
- Immunology
- Adverse events (MAUDE)
- 1995: 1
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 |
|---|---|---|
| LPIA-FERRITIN ASSAY (K924186) | Seradyn, Inc. | 1992-12-23 |
Track DEF automatically
Every clearance here is in the API, with alerts when new ones post.