FDA 510(k) Application Details - K083052

Device Classification Name	Antibodies, Gliadin   More FDA Info for this Device
510(K) Number	K083052
Device Name	Antibodies, Gliadin
Applicant	EUROIMMUN US INC 95 WASHINGTON ST MORRISTOWN, NJ 07960 US Other 510(k) Applications for this Company
Contact	KATHRYN KOHL Other 510(k) Applications for this Contact
Regulation Number	866.5750   More FDA Info for this Regulation Number
Classification Product Code	MST Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2008
Decision Date	07/28/2009
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