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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K211079	BioFire Defense, LLC	BioFire COVID-19 Test 2	11/01/2021
K221460	BioFire Defense, LLC	BioFire COVID-19 Test 2	07/25/2022
K212147	DiaSorin Molecular LLC	Simplexa COVID-19 Direct	09/13/2022
K231306	Roche Molecular Systems, Inc.	cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems	06/01/2023
K213804	Roche Molecular Systems, Inc.	cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems	10/22/2022