FDA 510(k) Application Details - K243222

Device Classification Name	More FDA Info for this Device
510(K) Number	K243222
Device Name	BIOFIRE« FILMARRAY« Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE« FILMARRAY« Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
Applicant	BioFire Diagnostics, LLC (bioMerieux) 515 Colorow Drive Salt Lake City, UT 84108 US Other 510(k) Applications for this Company
Contact	Karli Plenert 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	10/07/2024
Decision Date	11/06/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review