Source document or public record
FDA 510(k) K253358 — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
FDA 510(k) index record K253358. Device: Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay. Applicant as listed: Diazyme Laboratories, Inc.. Decision date: 2025-12-19.
Source
"device_name": "Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K253358.
Device name: Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay. Applicant as listed: Diazyme Laboratories, Inc..
Decision date: 2025-12-19. Decision wording: Substantially Equivalent.
Product code: DFH. Regulation: 21 CFR 866.5550. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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