Submission Details
| 510(k) Number | K253358 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (?) Free Light Chain Assay
Dec 2025
Decision
80d
Days
Class 2
Risk
About This 510(k) Submission
K253358 is an FDA 510(k) clearance for the Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (?) Free Light Chain Assay, 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 review panel. Regulated under 21 CFR 866.5550.
Device Classification
| Product Code | DFH — Kappa, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5550 |
Manufacturer
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