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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name simple point-of-care device to directly detect sars-cov-2 viral targets from clinical specimens in near-patient settings
510(k) Number K233688
Device Name Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
Quidel Corporation
10165 McKellar Court
San Diego,  CA  92121
Applicant Contact Xiaoxi Wang
Quidel Corporation
10165 McKellar Court
San Diego,  CA  92121
Correspondent Contact Xiaoxi Wang
Regulation Number866.3982
Classification Product Code
Date Received11/17/2023
Decision Date 12/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No