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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Autoantibodies, Endomysial(Tissue Transglutaminase)
510(k) Number K102490
Device Name IGX PLEX CELIAC QUALITATIVE ASSAY
Applicant
Sqi Diagnostics Systems
36 Meteor Dr.
Toronto, On,  CA M9W 1A4
Applicant Contact Kate Smith
Correspondent
Sqi Diagnostics Systems
36 Meteor Dr.
Toronto, On,  CA M9W 1A4
Correspondent Contact Kate Smith
Regulation Number866.5660
Classification Product Code
MVM  
Date Received08/31/2010
Decision Date 06/02/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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