FDA 510(k) Application Details - K163636

Device Classification Name	Respiratory Virus Panel Nucleic Acid Assay System   More FDA Info for this Device
510(K) Number	K163636
Device Name	Respiratory Virus Panel Nucleic Acid Assay System
Applicant	GENMARK DIAGNOSTICS, INCORPORATED 5964 LA PLACE COURT CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	ALAN MADERAZO Other 510(k) Applications for this Contact
Regulation Number	866.3980   More FDA Info for this Regulation Number
Classification Product Code	OCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2016
Decision Date	06/09/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review