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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 K120056
Models LK016.S, LK018.S
Device Name HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER
Original Applicant
THE BINDING SITE GROUP LTD
8 calthorpe road
edgbaston
birmingham, west midlands,  UK b15 1qt
Original Contact jill constantine
Regulation Number866.5550
Classification Product Code
DFH  
Date Received01/09/2012
Decision Date 04/01/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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