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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
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