K253358 is an FDA 510(k) clearance for the Diazyme Human Kappa (k) Free Light Chain Assay. This device is classified as a Kappa, Antigen, Antiserum, Control (Class II - Special Controls, product code DFH).
Submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on December 19, 2025, 80 days after receiving the submission on September 30, 2025.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K253358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2025 |
| Decision Date | December 19, 2025 |
| Days to Decision | 80 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 |