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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kappa, antigen, antiserum, control
510(k) Number K231290
Device Name Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
Applicant
The Binding Site Ltd.
8 Calthorpe Road
Birmingham,  GB B15 1QT
Applicant Contact Jolanta Wolff
Correspondent
The Binding Site Ltd.
8 Calthorpe Road
Birmingham,  GB B15 1QT
Correspondent Contact Jolanta Wolff
Regulation Number866.5550
Classification Product Code
DFH  
Subsequent Product Code
DEH  
Date Received05/04/2023
Decision Date 01/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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