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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoglobulin G Kappa Heavy And Light Chain Combined
510(k) Number K161854
Device Name Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
Applicant
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Edgbaston,  GB B15 1qt
Applicant Contact ANDREA THOMAS
Correspondent
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Edgbaston,  GB B15 1qt
Correspondent Contact ANDREA THOMAS
Regulation Number866.5510
Classification Product Code
PCN  
Subsequent Product Code
PCO  
Date Received07/06/2016
Decision Date 10/04/2016
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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