K214068 is an FDA 510(k) clearance for the Quantia IgE. This device is classified as a Ige, Antigen, Antiserum, Control (Class II - Special Controls, product code DGC).
Submitted by Biokit, S.A. (Lliçà D´Amunt, ES). The FDA issued a Cleared decision on February 21, 2023, 421 days after receiving the submission on December 27, 2021.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K214068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2021 |
| Decision Date | February 21, 2023 |
| Days to Decision | 421 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DGC — Ige, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |