FDA 510(k) Application Details - K202382

Device Classification Name	More FDA Info for this Device
510(K) Number	K202382
Device Name	FilmArray Global Fever Panel External Control Kit
Applicant	BioFire Defense, LLC 79 West 4500 South, Suite 14 Salt Lake City, UT 84107 US Other 510(k) Applications for this Company
Contact	Cynthia Phillips Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/2020
Decision Date	11/20/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review