FDA 510(k) Application Details - K221885

Device Classification Name	More FDA Info for this Device
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 US Other 510(k) Applications for this Company
Contact	Marianna Frendo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2022
Decision Date	10/26/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MG -
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review