FDA 510(k) Applications Submitted by CYNTHIA PHILLIPS

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
K131729 06/12/2013 JBAIDS PLAGUE DETECTION KIT BIOFIRE DIAGNOSTICS, INC.
DEN200043 06/26/2020 FilmArray Global Fever Panel BioFire Defense, LLC
K131930 06/27/2013 JBAIDS ANTHRAX DETECTION KIT BIOFIRE DIAGNOSTICS, INC.
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


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