FDA 510(k) Application Details - DEN160048

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160048
Device Name	FilmArray NGDS Warrior Panel
Applicant	BioFire Defense, LLC 79 West 4500 South, Suite 14 Salt Lake City, UT 84107 US Other 510(k) Applications for this Company
Contact	Cynthia Phillips Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PRD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/17/2016
Decision Date	02/14/2017
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review