FDA 510(k) Application Details - K091741

Device Classification Name	Immunochemical, Ceruloplasmin   More FDA Info for this Device
510(K) Number	K091741
Device Name	Immunochemical, Ceruloplasmin
Applicant	Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	KATHIE J GOODWIN Other 510(k) Applications for this Contact
Regulation Number	866.5210   More FDA Info for this Regulation Number
Classification Product Code	CHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2009
Decision Date	03/18/2010
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