FDA 510(k) Application Details - K071692

Device Classification Name	Autoantibodies, Endomysial(Tissue Transglutaminase)   More FDA Info for this Device
510(K) Number	K071692
Device Name	Autoantibodies, Endomysial(Tissue Transglutaminase)
Applicant	THERATEST LABORATORIES, INC. 1111 N. MAIN ST. LOMBARD, IL 60148 US Other 510(k) Applications for this Company
Contact	MARIUS TEODORESCU 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	06/20/2007
Decision Date	11/05/2007
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