FDA 510(k) Application Details - K131729

Device Classification Name	Yersinia Spp. Reagents   More FDA Info for this Device
510(K) Number	K131729
Device Name	Yersinia Spp. Reagents
Applicant	BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City, UT 84108 US Other 510(k) Applications for this Company
Contact	CYNTHIA PHILLIPS Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2013
Decision Date	07/31/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review