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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cancer predisposition risk assessment system
510(k) Number K223597
Device Name 23andMe® Personal Genome Service® (PGS®) Cancer Predisposition Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
Applicant
23andMe, Inc.
349 Oyster Point Blvd
South San Francisco,  CA  94080
Applicant Contact Marianna Frendo
Correspondent
23andMe, Inc.
349 Oyster Point Blvd
South San Francisco,  CA  94080
Correspondent Contact Marianna Frendo
Regulation Number866.6090
Classification Product Code
QAZ  
Date Received12/02/2022
Decision Date 08/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Molecular Genetics
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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