FDA 510(k) Application Details - K021660

Device Classification Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K021660
Device Name	Lipoprotein, Low-Density, Antigen, Antiserum, Control
Applicant	KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. SEATTLE, WA 98188-3412 US Other 510(k) Applications for this Company
Contact	BRIAN SCHLIESMAN Other 510(k) Applications for this Contact
Regulation Number	866.5600   More FDA Info for this Regulation Number
Classification Product Code	DFC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2002
Decision Date	07/25/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review