FDA 510(k) Application Details - DEN140044

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140044
Device Name	23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
Applicant	23andMe 1390 Shorebird Way Mountain View, CA 94043 US Other 510(k) Applications for this Company
Contact	Kathy Hibbs Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/29/2014
Decision Date	02/19/2015
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review