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FDA 510(k) Application Details - K150658
Device Classification Name
Kappa, Antigen, Antiserum, Control
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510(K) Number
K150658
Device Name
Kappa, Antigen, Antiserum, Control
Applicant
THE BINDING SITE GROUP LTD
8 CALTHORPE ROAD,
BIRMINGHAM B15 1QT GB
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Contact
Andrea Thomas
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Regulation Number
866.5550
More FDA Info for this Regulation Number
Classification Product Code
DFH
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More FDA Info for this Product Code
Date Received
03/13/2015
Decision Date
08/26/2015
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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