FDA 510(k) Application Details - K093459

Device Classification Name	Antibodies, Gliadin   More FDA Info for this Device
510(K) Number	K093459
Device Name	Antibodies, Gliadin
Applicant	PHADIA US INC. 4169 COMMERCIAL AVE. PORTAGE, MI 49002 US Other 510(k) Applications for this Company
Contact	MARTIN ROBERT MANN 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	11/06/2009
Decision Date	08/13/2010
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