FDA 510(k) Applications for Medical Device Product Code: OAU (Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma)

FDA 510(k) Applications for Medical Device Product Code "OAU"
(Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K062368	WAKO CHEMICALS, USA, INC.	WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401	01/31/2007