FDA 510(k) Application Details - K012359

Device Classification Name	Complement C4, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K012359
Device Name	Complement C4, Antigen, Antiserum, Control
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	HELEN T TORNEY Other 510(k) Applications for this Contact
Regulation Number	866.5240   More FDA Info for this Regulation Number
Classification Product Code	DBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2001
Decision Date	11/29/2001
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