FDA 510(k) Application Details - K181324

Device Classification Name	More FDA Info for this Device
510(K) Number	K181324
Device Name	FilmArray Pneumonia Panel plus
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	QDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2018
Decision Date	11/15/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review