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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 K120750
Model LK012.L.S.
Device Name HUMAN IGM CSF KIT
Original Applicant
THE BINDING SITE GROUP LTD
8 calthorpe road
edgbaston
birmingham, west midlands,  UK b15 1qt
Original Contact jill constantine
Regulation Number866.5510
Classification Product Code
CFN  
Date Received03/12/2012
Decision Date 05/17/2013
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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