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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name direct-to-consumer access pharmacogenetic assessment system
510(k) Number K193492
Device Name 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
23andMe, Inc.
223 N Mathilda Ave
Sunnyvale,  CA  94086
Applicant Contact Lisa Charter
23andMe, Inc.
223 N Mathilda Ave
Sunnyvale,  CA  94086
Correspondent Contact Marianna Frendo
Regulation Number862.3364
Classification Product Code
Date Received12/17/2019
Decision Date 08/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Molecular Genetics
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No