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FDA 510(k) Application Details - K151759
Device Classification Name
Immunoglobulin A Kappa Heavy & Light Chain Combined
More FDA Info for this Device
510(K) Number
K151759
Device Name
Immunoglobulin A Kappa Heavy & Light Chain Combined
Applicant
THE BINDING SITE GROUP LTD.
8 CALTROPE ROAD
EDGBASTON B15 1QT GB
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Contact
STEPHANIE THOULESS
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Regulation Number
866.5510
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Classification Product Code
OPX
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More FDA Info for this Product Code
Date Received
06/29/2015
Decision Date
11/06/2015
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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