FDA 510(k) Application Details - K163367

Device Classification Name	More FDA Info for this Device
510(K) Number	K163367
Device Name	GenetiSure Dx Postnatal Assay
Applicant	Agilent Technologies, Inc. 5301 Stevens Creek Blvd. Santa Clara, CA 95051 US Other 510(k) Applications for this Company
Contact	Lois Nakayama Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2016
Decision Date	08/11/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MG -
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review