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FDA 510(k) Applications for Medical Device Product Code "QVF"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K250273
Abbott Diagnostics Scarborough, Inc.
BinaxNOW COVID-19 Ag Card
06/13/2025
K243872
Becton, Dickinson and Company
BD Veritor System for SARS-CoV-2
06/16/2025
K232377
Healgen Scientific LLC
Healgen Rapid COVID-19 Antigen Test
04/19/2024
K233358
InBios International, Inc.
SCoV-2 Ag Detect Rapid Test
08/23/2024
K231187
Nano-Ditech Corporation
Nano-CheckÖ COVID-19 Antigen Test
01/23/2024
DEN220039
Quidel Corporation
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
03/08/2023
K233688
Quidel Corporation
Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
12/13/2023
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