FDA 510(k) Application Details - K170604

Device Classification Name	Respiratory Virus Panel Nucleic Acid Assay System   More FDA Info for this Device
510(K) Number	K170604
Device Name	Respiratory Virus Panel Nucleic Acid Assay System
Applicant	BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City, UT 84108 US Other 510(k) Applications for this Company
Contact	Kristen J. Kanack 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	03/01/2017
Decision Date	05/30/2017
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