K231290 is an FDA 510(k) clearance for the Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit. This device is classified as a Kappa, Antigen, Antiserum, Control (Class II - Special Controls, product code DFH).
Submitted by The Binding Site, Ltd. (Birmingham, GB). The FDA issued a Cleared decision on January 24, 2024, 265 days after receiving the submission on May 4, 2023.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K231290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2023 |
| Decision Date | January 24, 2024 |
| Days to Decision | 265 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 |