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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
510(k) Number K250159
Device Name Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
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 Number866.5510
Classification Product Code
SGG  
Subsequent Product Code
OTA  
Date Received01/21/2025
Decision Date 10/17/2025
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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