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FDA 510(k) Application Details - K120749
Device Classification Name
Method, Nephelometric, Immunoglobulins (G, A, M)
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510(K) Number
K120749
Device Name
Method, Nephelometric, Immunoglobulins (G, A, M)
Applicant
THE BINDING SITE GROUP LTD
8 CALTHORPE ROAD
EDGBASTON
BIRMINGHAM, WEST MIDLANDS B15 1QT GB
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JILL CONSTANTINE
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Regulation Number
866.5510
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Classification Product Code
CFN
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Date Received
03/12/2012
Decision Date
05/17/2013
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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