23andMe, Inc

FDA Filings

This page includes the latest FDA filings for 23andMe, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate
23andMe, Inc.
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports2018-10-31
23andMe, Inc.
23andMe PGS Genetic Health Risk Report For BRCA1/BRCA2 (Selected Variants)2018-03-06
23andMe
23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)2015-02-19

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
23andMe, Inc. Personal Genome Service®(PGS)
23ANDME, INC.2019-07-05
23andMe, Inc. Personal Genome Service®(PGS)
23ANDME, INC.2019-06-27
23andMe, Inc. Personal Genome Service®
23ANDME, INC.2018-10-29

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.