OAU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6030
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 (K062368) | Wako Chemicals USA, Inc. | 2007-01-31 |
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Every clearance here is in the API, with alerts when new ones post.