# CDN: Urease, Photometric, Urea Nitrogen

- Device class: 2; regulation: 21 CFR 862.1770; FDA's rule: 510(k) required
- FDA decisions: 16
- 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)
- 1991: 1
- 1992: 1
- 1994: 1
- 1996: 1
- 1997: 1
- 2000: 1
- 2011: 1
- 2012: 1
- 2013: 2
- 2019: 1

## Most-cited predicates
- K001885: Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1 (2000), cited by 2

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