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FDA 510(k) Application Details - K011662
Device Classification Name
Transferrin, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K011662
Device Name
Transferrin, Antigen, Antiserum, Control
Applicant
THE BINDING SITE, LTD.
WEST TOWER, SUITE 4000
2425 WEST OLYMPIC BOULEVARD
SANTA MONICA, CA 90404 US
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Contact
JAY H GELLER
Other 510(k) Applications for this Contact
Regulation Number
866.5880
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Classification Product Code
DDG
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More FDA Info for this Product Code
Date Received
05/29/2001
Decision Date
07/30/2001
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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