FDA 510(k) Application Details - K182784

Device Classification Name	More FDA Info for this Device
510(K) Number	K182784
Device Name	MUTYH-Associated Polyposis (MAP)
Applicant	23andMe, Inc. 899 W. Evelyn Ave., CA Mountain View, CA 94041 US Other 510(k) Applications for this Company
Contact	Sarah Rys 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	10/01/2018
Decision Date	01/18/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MG -
Review Advisory Committee	MG -
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review