FDA 510(k) Application Details - K243463

Device Classification Name	More FDA Info for this Device
510(K) Number	K243463
Device Name	BIOFIRE FILMARRAY Tropical Fever Panel
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	QMV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2024
Decision Date	12/05/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review