FDA 510(k) Application Details - DEN160026

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160026
Device Name	23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
Applicant	23andMe, Inc. 899 West Evelyn Avenue 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	PTA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2016
Decision Date	04/06/2017
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review