FDA 510(k) Application Details - K993345

Device Classification Name	Alpha-1-Lipoprotein, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K993345
Device Name	Alpha-1-Lipoprotein, 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	866.5580   More FDA Info for this Regulation Number
Classification Product Code	DER Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/05/1999
Decision Date	10/25/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review