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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoglobulin M Kappa Heavy And Light Chain Combined
510(k) Number K152389
Device Name Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
Applicant
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Birmingham,  GB B15 1QT
Applicant Contact STEPHANIE THOULESS
Correspondent
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Birmingham,  GB B15 1QT
Correspondent Contact STEPHANIE THOULESS
Regulation Number866.5510
Classification Product Code
PDE  
Subsequent Product Code
PDF  
Date Received08/24/2015
Decision Date 12/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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