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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 K221885
Device Name 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
Applicant
23andMe, Inc.
349 Oyster Point Blvd
South San Francisco,  CA  94080
Applicant Contact Marianna Frendo
Correspondent
23andMe, Inc.
349 Oyster Point Blvd
South San Francisco,  CA  94080
Correspondent Contact Marianna Frendo
Regulation Number862.3364
Classification Product Code
QDJ  
Date Received06/29/2022
Decision Date 10/26/2022
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
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