FDA 510(k) Application Details - K140691

Device Classification Name	Autoantibodies, Endomysial(Tissue Transglutaminase)   More FDA Info for this Device
510(K) Number	K140691
Device Name	Autoantibodies, Endomysial(Tissue Transglutaminase)
Applicant	SQI DIAGNOSTICS SYSTEMS INC. 36 Meteor Dr. TORONTO, ON M9W 1A4 CA Other 510(k) Applications for this Company
Contact	Kate Smith Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MVM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/19/2014
Decision Date	11/06/2014
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