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FDA 510(k) Application Details - K051299
Device Classification Name
Igd, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K051299
Device Name
Igd, Antigen, Antiserum, Control
Applicant
THE BINDING SITE LTD.
2425 WEST OLYMPIC BOULEVARD
WEST TOWER, SUITE 4000
SANTA MONICA, CA 90404 US
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Contact
JAY H GELLER
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Regulation Number
866.5510
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Classification Product Code
CZJ
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More FDA Info for this Product Code
Date Received
05/18/2005
Decision Date
11/23/2005
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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