FDA 510(k) Application Details - K061408

Device Classification Name	Autoantibodies, Endomysial(Tissue Transglutaminase)   More FDA Info for this Device
510(K) Number	K061408
Device Name	Autoantibodies, Endomysial(Tissue Transglutaminase)
Applicant	EUROIMMUN US LLC 429 ROCKAWAY VALLEY RD. UNIT 1200 BOONTON TWP, NJ 07005 US Other 510(k) Applications for this Company
Contact	KATHRYN KOHL 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	05/22/2006
Decision Date	10/05/2006
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