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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 K250549
Device Name Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
Applicant
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Birmingham,  GB B15 1QT
Applicant Contact Jolanta Wolff
Correspondent
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Birmingham,  GB B15 1QT
Correspondent Contact Jolanta Wolff
Regulation Number866.5550
Classification Product Code
DFH  
Subsequent Product Code
DEH  
Date Received02/25/2025
Decision Date 05/23/2025
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
Predetermined Change
Control Plan Authorized		 No
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