DGP — Ige, Fitc, Antigen, Antiserum, Control Class II
FDA product code DGP covers "Ige, Fitc, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5510. Submissions are reviewed by the Immunology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DGP
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K931224 | biomerieux vitek | VIDAS TOTAL IGE (IGE) ASSAY | May 20, 1993 |
| K863327 | sclavo | IMMPULSE IGE ASSAY REAGENTS | December 3, 1986 |
| K842969 | allergenetics | ALLERGENETICS ALLER-SPECIFIC IGE SERUM | August 28, 1984 |
| K842749 | intl. diagnostic technology | FIAX TOTAL IGE TEST KIT | August 28, 1984 |