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FDA 510(k) Application Details - K113349
Device Classification Name
Complement C9, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K113349
Device Name
Complement C9, Antigen, Antiserum, Control
Applicant
THE BINDING SITE GROUP LTD
8 CALTHORPE ROAD
EDGBASTON
BIRMINGHAM, WEST MIDLANDS B15 1QT GB
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Contact
MARIANNE SENDER
Other 510(k) Applications for this Contact
Regulation Number
866.5240
More FDA Info for this Regulation Number
Classification Product Code
DAE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/14/2011
Decision Date
07/11/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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