Source document or public record
FDA 510(k) K221885 — 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
FDA 510(k) index record K221885. Device: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports. Applicant as listed: 23AndMe, Inc.. Decision date: 2022-10-26.
Source
"device_name": "23andMe Personal Genome Service (PGS) Pharmacogenetic Reports"
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 K221885.
Device name: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports. Applicant as listed: 23AndMe, Inc..
Decision date: 2022-10-26. Decision wording: Substantially Equivalent.
Product code: QDJ. Regulation: 21 CFR 862.3364. 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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