FDA Product Code
FDA Product Code DGP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K931224 | VIDAS TOTAL IGE (IGE) ASSAY | Biomerieux Vitek, Inc. | 1993-05-20 | Traditional | PDF ↗ |
| K863327 | IMMPULSE IGE ASSAY REAGENTS | Sclavo, Inc. | 1986-12-03 | Traditional | PDF ↗ |
| K842749 | FIAX TOTAL IGE TEST KIT | Intl. Diagnostic Technology | 1984-08-28 | Traditional | PDF ↗ |
| K842969 | ALLERGENETICS ALLER-SPECIFIC IGE SERUM | Allergenetics | 1984-08-28 | Traditional | PDF ↗ |
Product code DGP · Class II · Immunology. Data: openFDA.