K210623 is an FDA 510(k) clearance for the FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2. This device is classified as a Kappa, Antigen, Antiserum, Control (Class II - Special Controls, product code DFH).
Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on November 18, 2022, 626 days after receiving the submission on March 2, 2021.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K210623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2021 |
| Decision Date | November 18, 2022 |
| Days to Decision | 626 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DFH — Kappa, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |