Source document or public record
FDA 510(k) K211648 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
FDA 510(k) index record K211648. Device: Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay. Applicant as listed: Diazyme Laboratories, Inc.. Decision date: 2022-09-08.
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"device_name": "Diazyme Human Kappa 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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2026-10-20
2026-10-20
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FDA 510(k) public index record K211648.
Device name: Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay. Applicant as listed: Diazyme Laboratories, Inc..
Decision date: 2022-09-08. 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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