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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 K243518
Device Name BinaxNOW™ COVID-19 Antigen Self Test; BinaxNOW™ COVID-19 Ag Card
Applicant
Abbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough,  ME  04074
Applicant Contact Kristen Cyr
Correspondent
Abbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough,  ME  04074
Correspondent Contact Kristen Cyr
Classification Product Code
QYT  
Date Received11/13/2024
Decision Date 02/11/2025
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
Predetermined Change
Control Plan Authorized		 No
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