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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name over-the-counter covid-19 antigen test
510(k) Number K231795
Device Name QuickVue COVID-19 Test
Applicant
Quidel Corporation
10165 McKellar Court
San Diego,  CA  92121
Applicant Contact Suzanne Thomas
Correspondent
Quidel Corporation
10165 McKellar Court
San Diego,  CA  92121
Correspondent Contact Suzanne Thomas
Regulation Number866.3984
Classification Product Code
QYT  
Date Received06/20/2023
Decision Date 03/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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