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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
Device Name HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
Applicant
THE BINDING SITE GROUP, LTD.
8 CALTHORPE ROAD
WEST MIDLANDS
EDGBASTON,  GB B15 1QT
Applicant Contact JILL CONSTANTINE
Correspondent
THE BINDING SITE GROUP, LTD.
8 CALTHORPE ROAD
WEST MIDLANDS
EDGBASTON,  GB B15 1QT
Correspondent Contact JILL CONSTANTINE
Regulation Number866.5250
Classification Product Code
DBA  
Date Received08/01/2012
Decision Date 04/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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