FDA 510(k) Application Details - K100464

Device Classification Name	Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment   More FDA Info for this Device
510(K) Number	K100464
Device Name	Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
Applicant	WAKO CHEMICALS USA, INC. 1025 TERRA BELLA AVE SUITE A MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	MARTHA MURARI 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	02/18/2010
Decision Date	02/23/2011
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