FDA 510(k) Application Details - DEN150013

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150013
Device Name	FilmArray Meningitis/Encephalitis(ME) Panel
Applicant	BioFire Diagnostics, LLC 390 Wakara Way 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	More FDA Info for this Regulation Number
Classification Product Code	PLO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/09/2015
Decision Date	10/08/2015
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review