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FDA 510(k) Application Details - K143118
Device Classification Name
Albumin, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K143118
Device Name
Albumin, Antigen, Antiserum, Control
Applicant
THE BINDING SITE GROUP LTD
8 CALTHORPE ROAD,
BIRMINGHAM B15 1QT GB
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Contact
Marianne Sender
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Regulation Number
866.5040
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Classification Product Code
DCF
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More FDA Info for this Product Code
Date Received
10/30/2014
Decision Date
05/26/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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