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

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..

Clearance details

Applicant: 23AndMe, Inc.
Product code: Code QAZ
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

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