FDA 510(k) Application Details - K050665

Device Classification Name	Complement C3, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K050665
Device Name	Complement C3, Antigen, Antiserum, Control
Applicant	DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG. 500 M.S. 514; POX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	DONNA A WOLF Other 510(k) Applications for this Contact
Regulation Number	866.5240   More FDA Info for this Regulation Number
Classification Product Code	CZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2005
Decision Date	05/02/2005
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