FDA 510(k) Application Details - DEN200066

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200066
Device Name	BioFire Joint Infection (JI) Panel
Applicant	BioFire Diagnostics, LLC 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	QSN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2020
Decision Date	04/29/2022
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review