23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)— 510(k) K223597

Name: FDA 510(k) clearance K223597
Creator: U.S. Food and Drug Administration
Published: 2023-08-31

Substantially Equivalent

23AndMe, Inc.

FDA 510(k) clearance K223597 for 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants), Substantially Equivalent on 2023-08-31. Applicant: 23AndMe, Inc.. Device class: 2.

Clearance details

Applicant: 23AndMe, Inc.
Product code: Code QAZ
Device class: Class 2
Regulation: 21 CFR 866.6090
Advisory panel: Medical Genetics
Date received: 2022-12-02
Decision date: 2023-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Franciso, CA, US

Download summary PDF View on FDA.gov ↗

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K211499 — 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)2022-01-06
K182784 — MUTYH-Associated Polyposis (MAP)2019-01-18
DEN170046 — 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)2018-03-06

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K221885 — 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports2022-10-26
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DEN180028 — 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports2018-10-31
DEN160026 — 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia2017-04-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.