FDA 510(k) Applications Submitted by BioFire Diagnostics, LLC (bioMerieux)

FDA 510(k) Number Submission Date Device Name Applicant
K243222 10/07/2024 BIOFIRE« FILMARRAY« Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE« FILMARRAY« Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) BioFire Diagnostics, LLC (bioMerieux)
K243463 11/08/2024 BIOFIRE FILMARRAY Tropical Fever Panel BioFire Diagnostics, LLC (bioMerieux)


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