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FDA 510(k) Application Details - K123256
Device Classification Name
Alpha-1-Antitrypsin, Antigen, Antiserum, Control
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510(K) Number
K123256
Device Name
Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Applicant
THE BINDING SITE GROUP, LTD.
8 CALTHORPE ROAD
EDGBASTON
BIRMINGHAM, WEST MIDLANDS B15 1QT GB
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Contact
JILL CONSTANTINE
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Regulation Number
866.5130
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Classification Product Code
DEM
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More FDA Info for this Product Code
Date Received
10/18/2012
Decision Date
07/03/2013
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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