FDA 510(k) Application Details - K143178

Device Classification Name	Instrumentation For Clinical Multiplex Test Systems   More FDA Info for this Device
510(K) Number	K143178
Device Name	Instrumentation For Clinical Multiplex Test Systems
Applicant	BioFire Diagnostics, LLC 390 Wakara Way Salt Lake City, UT 84108 US Other 510(k) Applications for this Company
Contact	Kristen Kanack, PhD Other 510(k) Applications for this Contact
Regulation Number	862.2570   More FDA Info for this Regulation Number
Classification Product Code	NSU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/2014
Decision Date	01/30/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review