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FDA 510(k) Application Details - K070900
Device Classification Name
Kappa, Antigen, Antiserum, Control
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510(K) Number
K070900
Device Name
Kappa, Antigen, Antiserum, Control
Applicant
THE BINDING SITE, LTD.
EAST TOWER, SUITE 600
2425 WEST OLYMPIC BOULEVARD
SANTA MONICA, CA 90404 US
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Contact
JAY H GELLER
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Regulation Number
866.5550
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Classification Product Code
DFH
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More FDA Info for this Product Code
Date Received
04/02/2007
Decision Date
11/30/2007
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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