FDA 510(k) Application Details - K192944

Device Classification Name	More FDA Info for this Device
510(K) Number	K192944
Device Name	AncestryDNA Factor V Leiden Genetic Health Risk Test
Applicant	Ancestry Genomics, Inc. 153 Townsend Street, Suite 800 San Francisco, CA 94107 US Other 510(k) Applications for this Company
Contact	Raajdeep Venkatesan 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	10/18/2019
Decision Date	08/13/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review