FDA 510(k) Application Details - DEN170046

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170046
Device Name	23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
Applicant	23andMe, Inc. 899 W.Evelyn Ave Mountain View, CA 94041 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	QAZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2017
Decision Date	03/06/2018
Decision	DENG -
Classification Advisory Committee	MG -
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review