23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

Direct-to-consumer Access Pharmacogenetic Assessment System

23andMe, Inc.

The following data is part of a De Novo classification by 23andme, Inc. with the FDA for 23andme Personal Genome Service (pgs) Pharmacogenetic Reports.

Pre-market Notification Details

DeNovo IDDEN180028
Device Name:23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
ClassificationDirect-to-consumer Access Pharmacogenetic Assessment System
Applicant 23andMe, Inc. 899 W. Evelyn Ave., Mountain View,  CA  94041
ContactAdam Odeh
Product CodeQDJ  
CFR Regulation Number862.3364 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardClinical Chemistry
Classification AdvisoryMolecular Genetics
Date Received2018-06-05
Decision Date2018-10-31
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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