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 |
| K243822 |
12/12/2024 |
BioFire Warrior Panel; BioFire Warrior Panel Control Kit |
BioFire Defense, LLC |
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