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FDA 510(k) Application Details - K040466
Device Classification Name
Autoantibodies, Endomysial(Tissue Transglutaminase)
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510(K) Number
K040466
Device Name
Autoantibodies, Endomysial(Tissue Transglutaminase)
Applicant
THE BINDING SITE
WEST TOWER, SUITE 4000
2425 WEST OLYMPIC BLVD.
SANTA MONICA, CA 90404 US
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Contact
JAY H GELLER
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Regulation Number
866.5660
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Classification Product Code
MVM
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More FDA Info for this Product Code
Date Received
02/23/2004
Decision Date
07/16/2004
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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