FDA 510(k) Applications for Medical Device Product Code: QOF ()

FDA 510(k) Applications for Medical Device Product Code "QOF"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K230956	BD Integrated Diagnostic Solutions/	BD Respiratory Viral Panel for BD MAXÖ System; BD Respiratory Viral Panel-SCV2 for BD MAXÖ System	07/31/2023
K213954	BioFire Diagnostics	BIOFIRE SPOTFIRE Respiratory (R) Panel	02/03/2023
DEN200031	Biofire Diagnostics, LLC	BioFire Respiratory Panel 2.1 (RP2.1)	03/17/2021
K230719	Biofire Diagnostics, LLC	BIOFIRE« SPOTFIRE« Respiratory (R) Panel Mini	04/13/2023
K231481	Cepheid«	Xpert Xpress CoV-2/Flu/RSV plus	08/17/2023
K220963	DiaSorin Molecular LLC	Simplexa COVID-19 & Flu A/B Direct	03/17/2023
K222736	Hologic, Inc.	Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay	05/16/2023
K223591	Roche Molecular Systems, Inc.	cobas« SARS-CoV-2 & Influenza A/B for use on the cobas« Liat System	07/27/2023