Source document or public record
FDA 510(k) K253069 — Lipoprotein (a) Molarity Assay
FDA 510(k) index record K253069. Device: Lipoprotein (a) Molarity Assay. Applicant as listed: Diazyme Laboratories, Inc.. Decision date: 2026-06-16.
Source
"device_name": "Lipoprotein (a) Molarity 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
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FDA 510(k) public index record K253069.
Device name: Lipoprotein (a) Molarity Assay. Applicant as listed: Diazyme Laboratories, Inc..
Decision date: 2026-06-16. Decision wording: Substantially Equivalent.
Product code: DFC. Regulation: 21 CFR 866.5600. 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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