FDA 510(k) Application Details - K193492

Device Classification Name	More FDA Info for this Device
510(K) Number	K193492
Device Name	23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
Applicant	23andMe, Inc. 223 N Mathilda Ave Sunnyvale, CA 94086 US Other 510(k) Applications for this Company
Contact	Lisa Charter 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	12/17/2019
Decision Date	08/17/2020
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