FDA 510(k) Application Details - K011780

Device Classification Name	Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K011780
Device Name	Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Applicant	KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. SEATTLE, WA 98188-3412 US Other 510(k) Applications for this Company
Contact	COLIN GETTY 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	06/07/2001
Decision Date	07/25/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review