FDA 510(k) Application Details - K050113

Device Classification Name	Igg, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K050113
Device Name	Igg, Antigen, Antiserum, Control
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	THERESA M AMBROSE Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	DEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/18/2005
Decision Date	02/08/2005
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