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FDA 510(k) Application Details - K992878
Device Classification Name
Autoantibodies, Endomysial(Tissue Transglutaminase)
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510(K) Number
K992878
Device Name
Autoantibodies, Endomysial(Tissue Transglutaminase)
Applicant
IMMCO DIAGNOSTICS, INC.
60 PINEVIEW DR.
BUFFALO, NY 14228 US
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Contact
KEVIN LAWSON
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Regulation Number
866.5660
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Classification Product Code
MVM
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Date Received
08/26/1999
Decision Date
10/15/1999
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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