FDA 510(k) Application Details - K213954

Device Classification Name	More FDA Info for this Device
510(K) Number	K213954
Device Name	BIOFIRE SPOTFIRE Respiratory (R) Panel
Applicant	BioFire Diagnostics 515 Colorow Drive Salt Lake City, UT 84108 US Other 510(k) Applications for this Company
Contact	Kevin Bourzac Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2021
Decision Date	02/03/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review