FDA 510(k) Application Details - DEN180028

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180028
Device Name	23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
Applicant	23andMe, Inc. 899 W. Evelyn Ave., Mountain View, CA 94041 US Other 510(k) Applications for this Company
Contact	Adam Odeh 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	06/05/2018
Decision Date	10/31/2018
Decision	DENG -
Classification Advisory Committee	MG -
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review