# NCW: System, Test, Her-2/Neu, Monitoring

- Device class: 2; regulation: 21 CFR 866.6010; FDA's rule: 510(k) required
- FDA decisions: 3
- Recalls: 1 (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)
- 2000: 2
- 2003: 1

## Most-cited predicates
- K992228: Bayer Immuno 1 Her-2/Neu Assay (2000), cited by 1

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