# DEN050002: Lba Afp-L3, Afp-L3 Calibrator Set, Afp-L3 Control Set and Libasys

- Pathway: De Novo (Post-NSE)
- Applicant: Wako Chemicals USA, Inc.
- Decided: May 19, 2005 after 42 days
- Product code: NSF (Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment)
- Device class: 2
- Regulation: 21 CFR 866.6030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

Source page: https://510kreport.com/device/DEN050002
Methodology: https://510kreport.com/methodology