FDA 510(k) Applications Submitted by Karli Plenert

FDA 510(k) Number	Submission Date	Device Name	Applicant
K241194	04/30/2024	BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini	BioFire Diagnostics, LLC
K242367	08/09/2024	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel	BioFire Diagnostics, LLC
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)
K243759	12/06/2024	BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))	BioFire Diagnostics, LLC
K243885	12/18/2024	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid	BioFire Diagnostics, LLC