FDA 510(k) Applications Submitted by BioFire Defense, LLC

FDA 510(k) Number	Submission Date	Device Name	Applicant
K170883	03/24/2017	FilmArray NGDS Warrior Panel	BioFire Defense, LLC
K211079	04/12/2021	BioFire COVID-19 Test 2	BioFire Defense, LLC
K221460	05/19/2022	BioFire COVID-19 Test 2	BioFire Defense, LLC
DEN200043	06/26/2020	FilmArray Global Fever Panel	BioFire Defense, LLC
K202382	08/20/2020	FilmArray Global Fever Panel External Control Kit	BioFire Defense, LLC
K213362	10/12/2021	BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel	BioFire Defense, LLC
DEN160048	10/17/2016	FilmArray NGDS Warrior Panel	BioFire Defense, LLC
K220870	03/25/2022	BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel	BioFire Defense, LLC