FDA 510(k) Application Details - K170883

Device Classification Name	More FDA Info for this Device
510(K) Number	K170883
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	03/24/2017
Decision Date	06/22/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review