FDA 510(k) Applications for Medical Device Product Code: NSF (Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment)

FDA 510(k) Applications for Medical Device Product Code "NSF"
(Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K100464	WAKO CHEMICALS USA, INC.	UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION	02/23/2011
DEN050002	WAKO CHEMICALS, USA, INC.	LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS	05/19/2005