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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
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