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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name albumin, antigen, antiserum, control
510(k) Number K121045
Model NK032.L.S.
Device Name HUMAN ALBUMIN CSF KIT
Original Applicant
THE BINDING SITE GROUP, LTD.
8 calthorpe road
edgbaston,  UK b15 1qt
Original Contact jill constantine
Regulation Number866.5040
Classification Product Code
DCF  
Date Received04/06/2012
Decision Date 06/19/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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