DGC
- Product code
- DGC
- Device name
- Ige, Antigen, Antiserum, Control
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.5510
- Medical specialty
- Immunology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 114 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K231151 | 2024-05-31 | Kenota, Inc. | Kenota 1 Total IgE; Kenota 1 (instrument) |
Official FDA classification page: DGC
Classification and pathway per current FDA publications. Data from openFDA (CC0).