FDA 510(k) Application Details - K113377

Device Classification Name	Antibodies, Gliadin   More FDA Info for this Device
510(K) Number	K113377
Device Name	Antibodies, Gliadin
Applicant	GRIFOLS USA, LLC 2410 LILLYVALE AVE. LOS ANGELES, CA 90032 US Other 510(k) Applications for this Company
Contact	CATHERINE L WONG 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	11/16/2011
Decision Date	12/14/2012
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