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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 K211499
Device Name 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
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 Received05/14/2021
Decision Date 01/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Molecular Genetics
510k Review Panel Molecular Genetics
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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