# NSF: Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

- Device class: 2; regulation: 21 CFR 866.6030; FDA's rule: 510(k) required
- FDA decisions: 2
- 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)
- 2005: 1
- 2011: 1

## Most-cited predicates

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