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FDA 510(k) Application Details - K102490
Device Classification Name
Autoantibodies, Endomysial(Tissue Transglutaminase)
More FDA Info for this Device
510(K) Number
K102490
Device Name
Autoantibodies, Endomysial(Tissue Transglutaminase)
Applicant
SQI DIAGNOSTICS SYSTEMS
36 METEOR DR.
TORONTO, ONTARIO M9W 1A4 CA
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Contact
Kate Smith
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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
08/31/2010
Decision Date
06/02/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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