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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name cancer predisposition risk assessment system
De Novo Number DEN170046
Device Name 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
23andMe, Inc.
899 w.evelyn ave
mountain view,  CA  94041
Contact lisa charter
Regulation Number866.6090
Classification Product Code
Date Received09/05/2017
Decision Date 03/06/2018
Decision granted (DENG)
Classification Advisory Committee Molecular Genetics
Review Advisory Committee Pathology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct