FDA 510(k) Application Details - DEN050002

Device Classification Name	Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment   More FDA Info for this Device
510(K) Number	DEN050002
Device Name	Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
Applicant	WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US Other 510(k) Applications for this Company
Contact	TONYA MALLORY Other 510(k) Applications for this Contact
Regulation Number	866.6030   More FDA Info for this Regulation Number
Classification Product Code	NSF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2005
Decision Date	05/19/2005
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review