23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

Direct-to-consumer Access Pharmacogenetic Assessment System

23andMe, Inc.

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

Pre-market Notification Details

Device IDK221885
510k NumberK221885
Device Name:23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
ClassificationDirect-to-consumer Access Pharmacogenetic Assessment System
Applicant 23andMe, Inc. 349 Oyster Point Blvd South San Francisco,  CA  94080
ContactMarianna Frendo
CorrespondentMarianna Frendo
23andMe, Inc. 349 Oyster Point Blvd South San Francisco,  CA  94080
Product CodeQDJ  
CFR Regulation Number862.3364 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-29
Decision Date2022-10-26

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