DGP
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ige, Fitc, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- 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 |
|---|---|---|
| VIDAS TOTAL IGE (IGE) ASSAY (K931224) | Biomerieux Vitek, Inc. | 1993-05-20 |
| IMMPULSE IGE ASSAY REAGENTS (K863327) | Sclavo, Inc. | 1986-12-03 |
| ALLERGENETICS ALLER-SPECIFIC IGE SERUM (K842969) | Allergenetics | 1984-08-28 |
| FIAX TOTAL IGE TEST KIT (K842749) | Intl. Diagnostic Technology | 1984-08-28 |
Track DGP automatically
Every clearance here is in the API, with alerts when new ones post.