FDA 510(k) Application Details - K143171

Device Classification Name	More FDA Info for this Device
510(K) Number	K143171
Device Name	FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
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	More FDA Info for this Regulation Number
Classification Product Code	PEN 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	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review