23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)— 510(k) K211499

Substantially Equivalent

23AndMe, Inc.

FDA 510(k) clearance K211499 for 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related), Substantially Equivalent on 2022-01-06. Applicant: 23AndMe, Inc..

Clearance details

Applicant: 23AndMe, Inc.
Product code: Code QAZ
Advisory panel: Medical Genetics
Date received: 2021-05-14
Decision date: 2022-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Franciso, CA, US

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