FDA 510(k) Application Details - DEN170017

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170017
Device Name	FilmArray Respiratory Panel 2 plus (RP2plus)
Applicant	BioFire Diagnostics, LLC 515 Colorow Drive 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	PZF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2017
Decision Date	11/24/2017
Decision	DENG -
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review