23andMe Personal Genome Service (PGS) Genetic Health Risk Test For Hereditary Thrombophilia

Genetic Variant Detection And Health Risk 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) Genetic Health Risk Test For Hereditary Thrombophilia.

Pre-market Notification Details

DeNovo IDDEN160026
Device Name:23andMe Personal Genome Service (PGS) Genetic Health Risk Test For Hereditary Thrombophilia
ClassificationGenetic Variant Detection And Health Risk Assessment System
Applicant 23andMe, Inc. 899 West Evelyn Avenue Mountain View,  CA  94041
ContactLisa Charter
Product CodePTA  
CFR Regulation Number866.5950 [🔎]
DecisionGranted (DENG)
510(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 BoardHematology
Classification AdvisoryImmunology
TypeDirect
Date Received2016-06-28
Decision Date2017-04-06
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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