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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 genetic variant detection and health risk assessment system
De Novo Number DEN160026
Device Name 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
23andMe, Inc.
899 west evelyn avenue
mountain view,  CA  94041
Contact lisa charter
Regulation Number866.5950
Classification Product Code
Date Received06/28/2016
Decision Date 04/06/2017
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Hematology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct