FDA 510(k) Application Details - K131936

Device Classification Name	Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit   More FDA Info for this Device
510(K) Number	K131936
Device Name	Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
Applicant	BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City, UT 84108 US Other 510(k) Applications for this Company
Contact	CYNTHIA PHILIPS Other 510(k) Applications for this Contact
Regulation Number	866.3280   More FDA Info for this Regulation Number
Classification Product Code	OEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2013
Decision Date	07/31/2013
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