DGCClass II
Ige, Antigen, Antiserum, Control
21 CFR 866.5510 / Immunology
DGC is the FDA product code for Ige, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold 114 510(k) clearances under this code, the most recent dated , and 3 recalls.
Classification record
- Product code
- DGC
- Device name
- Ige, 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
- 114
- Ingested recalls
- 3
Clearances, product code DGC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 5 |
| 1982 | 12 |
| 1983 | 13 |
| 1984 | 14 |
| 1985 | 5 |
| 1986 | 8 |
| 1987 | 3 |
| 1988 | 5 |
| 1989 | 7 |
| 1990 | 4 |
| 1991 | 5 |
| 1992 | 3 |
| 1993 | 3 |
| 1994 | 2 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 4 |
| 2000 | 1 |
| 2001 | 1 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| 2007 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code DGC| Applicant | Clearances |
|---|---|
| Pharmacia, Inc. | 16 |
| Ventrex Laboratories, Inc. | 12 |
| Siemens Healthcare Diagnostics Inc. | 11 |
| Kallestad Laboratories, Inc. | 8 |
| Hybritech, Inc. | 4 |
| Allergenetics | 3 |
| Mast Immunosystems | 3 |
| Ortho-Clinical Diagnostics, Inc. | 3 |
| 3M Company | 2 |
| Abbott Medical | 2 |
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.