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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