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FDA 510(k) Application Details - K120236
Device Classification Name
Transferrin, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K120236
Device Name
Transferrin, 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
Other 510(k) Applications for this Contact
Regulation Number
866.5880
More FDA Info for this Regulation Number
Classification Product Code
DDG
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More FDA Info for this Product Code
Date Received
01/26/2012
Decision Date
02/13/2013
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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