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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