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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 K120901
Model LK010.L.S.
Device Name HUMAN IGA CSF KIT FOR USE ON SPAPLUS
Original Applicant
THE BINDING SITE GROUP, LTD.
8 calthorpe road
edgbaston,  UK b15 1qt
Original Contact jill constantine
Regulation Number866.5510
Classification Product Code
CFN  
Date Received03/26/2012
Decision Date 05/30/2013
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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