Source document or public record
FDA 510(k) K192944 — AncestryDNA Factor V Leiden Genetic Health Risk Test
FDA 510(k) index record K192944. Device: AncestryDNA Factor V Leiden Genetic Health Risk Test. Applicant as listed: Ancestry Genomics, Inc.. Decision date: 2020-08-13.
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"device_name": "AncestryDNA Factor V Leiden Genetic Health Risk Test"
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 K192944.
Device name: AncestryDNA Factor V Leiden Genetic Health Risk Test. Applicant as listed: Ancestry Genomics, Inc..
Decision date: 2020-08-13. Decision wording: Substantially Equivalent.
Product code: PTA. Regulation: 21 CFR 866.5950. 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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