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FDA 510(k) Application Details - K152389
Device Classification Name
More FDA Info for this Device
510(K) Number
K152389
Device Name
Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
Applicant
THE BINDING SITE GROUP LTD
8 CALTHORPE RD
EDGBASTON
BIRMINGHAM B15 1QT GB
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Contact
STEPHANIE THOULESS
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Regulation Number
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Classification Product Code
PDE
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More FDA Info for this Product Code
Date Received
08/24/2015
Decision Date
12/18/2015
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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