K231601 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 February 23, 2024, 267 days after receiving the submission on June 1, 2023.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K231601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2023 |
| Decision Date | February 23, 2024 |
| Days to Decision | 267 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 |