Product code OAU

Device name: Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
Medical specialty: Immunology
Device class: 2
Regulation number: 866.6030
Review panel: IM
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Definition: The test is intended to quantitatively measure dcp in human serum and use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma (hcc) in conjunction with other laboratory findings, imaging studies and clinical assessment for risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K062368	WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401	Wako Chemicals USA, Inc.	2007-01-31

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
04987481164413	uTASWako DCP	FUJIFILM WAKO PURE CHEMICAL CORPORATION	2020-10-23
00856626006120	uTASWako DCP	FUJIFILM WAKO PURE CHEMICAL CORPORATION	2016-12-07

Related 510(k) Records#