# CHN: Immunochemical, Ceruloplasmin

- Device class: 2; regulation: 21 CFR 866.5210; FDA's rule: 510(k) exempt
- FDA decisions: 3
- Recalls: 6 (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: 2
- 2010: 1

## Most-cited predicates
- K062114: Ceruloplasmin, Model 2055953 (2007), cited by 1

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