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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Nephelometric, Immunoglobulins (G, A, M)
510(k) Number K113823
Device Name HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
Applicant
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Birmingham,  GB B15 1QT
Applicant Contact JILL CONSTANTINE
Correspondent
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Birmingham,  GB B15 1QT
Correspondent Contact JILL CONSTANTINE
Regulation Number866.5510
Classification Product Code
CFN  
Subsequent Product Codes
PDE   PDF  
Date Received12/27/2011
Decision Date 03/27/2013
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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