Source document or public record
FDA 510(k) K211499 — 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
FDA 510(k) index record K211499. Device: 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related). Applicant as listed: 23AndMe, Inc.. Decision date: 2022-01-06.
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"device_name": "23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)"
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 K211499.
Device name: 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related). Applicant as listed: 23AndMe, Inc..
Decision date: 2022-01-06. 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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