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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name complement c1 inhibitor (inactivator), antigen, antiserum, control
510(k) Number K122304
Model NK019.S
Device Name HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
Original Applicant
THE BINDING SITE GROUP, LTD.
8 calthorpe road
west midlands
edgbaston,  UK b15 1qt
Original Contact jill constantine
Regulation Number866.5250
Classification Product Code
DBA  
Date Received08/01/2012
Decision Date 04/15/2013
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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