Source document or public record
FDA 510(k) K223597 — 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
FDA 510(k) index record K223597. Device: 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). Applicant as listed: 23AndMe, Inc.. Decision date: 2023-08-31.
Source
"device_name": "23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)"
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 K223597.
Device name: 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). Applicant as listed: 23AndMe, Inc..
Decision date: 2023-08-31. Decision wording: Substantially Equivalent.
Product code: QAZ. Regulation: 21 CFR 866.6090. Medical specialty: Medical Genetics.
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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