FDA 510(k) Application Details - K211499

Device Classification Name	More FDA Info for this Device
510(K) Number	K211499
Device Name	23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
Applicant	23andMe, Inc. 349 Oyster Point Blvd. South San Francisco, CA 94080 US Other 510(k) Applications for this Company
Contact	Marianna Frendo 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	05/14/2021
Decision Date	01/06/2022
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