FDA 510(k) Application Details - K010625

Device Classification Name	Autoantibodies, Endomysial(Tissue Transglutaminase)   More FDA Info for this Device
510(K) Number	K010625
Device Name	Autoantibodies, Endomysial(Tissue Transglutaminase)
Applicant	SCIMEDX CORP. 400 FORD RD. BLDG. 100 DENVILLE, NJ 07834 US Other 510(k) Applications for this Company
Contact	Gary Lehnus 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	03/02/2001
Decision Date	04/24/2001
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