DGPClass II
Ige, Fitc, Antigen, Antiserum, Control
21 CFR 866.5510 / Immunology
DGP is the FDA product code for Ige, Fitc, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- DGP
- Device name
- Ige, Fitc, Antigen, Antiserum, Control
- Regulation
- 21 CFR 866.5510
- Device class
- Class II
- Review panel
- Immunology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code DGP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 2 |
| 1986 | 1 |
| 1993 | 1 |
Applicants with the most clearances
Product code DGP| Applicant | Clearances |
|---|---|
| Allergenetics | 1 |
| Biomerieux Vitek, Inc. | 1 |
| Intl. Diagnostic Technology | 1 |
| Sclavo, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
