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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 direct-to-consumer access pharmacogenetic assessment system
De Novo Number DEN180028
Device Name 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
23andMe, Inc.
899 w. evelyn ave.,
mountain view,  CA  94041
Contact adam odeh
Regulation Number862.3364
Classification Product Code
Date Received06/05/2018
Decision Date 10/31/2018
Decision granted (DENG)
Classification Advisory Committee Molecular Genetics
Review Advisory Committee Clinical Chemistry
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct