FDA 510(k) Application Details - K003747

Device Classification Name	Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K003747
Device Name	Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Applicant	BAXTER HEALTHCARE CORP. 550 NORTH BRAND BLVD. GLENDALE, CA 91023 US Other 510(k) Applications for this Company
Contact	ARLENE VIDOR Other 510(k) Applications for this Contact
Regulation Number	866.5250   More FDA Info for this Regulation Number
Classification Product Code	DBA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2000
Decision Date	03/19/2001
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