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FDA 510(k) Applications Submitted by Kevin Bourzac
FDA 510(k) Number
Submission Date
Device Name
Applicant
K230404
02/15/2023
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
BioFire Diagnostics, LLC
K230719
03/15/2023
BIOFIRE« SPOTFIRE« Respiratory (R) Panel Mini
Biofire Diagnostics, LLC
K212727
08/27/2021
FilmArray Pneumonia Panel
BioFire Diagnostics, LLC
K222601
08/29/2022
FilmArray Pneumonia Panel plus
BioFire Diagnostics, LLC
DEN200066
10/27/2020
BioFire Joint Infection (JI) Panel
BioFire Diagnostics, LLC
K213954
12/17/2021
BIOFIRE SPOTFIRE Respiratory (R) Panel
BioFire Diagnostics
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