# OAU: Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

- Device class: 2; regulation: 21 CFR 866.6030; FDA's rule: 510(k) required
- FDA decisions: 1
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2007: 1

## Most-cited predicates
- K062368: Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP Calibrator Set, Libasys, Model 999-05401 (2007), cited by 1

Source page: https://510kreport.com/product-code/OAU
Data by year (CSV): https://510kreport.com/product-code/OAU.csv