# CDQ: Urease And Glutamic Dehydrogenase, Urea Nitrogen

- Device class: 2; regulation: 21 CFR 862.1770; FDA's rule: 510(k) required
- FDA decisions: 117
- 510(k) review time 2021–2025: median 524 days (middle half 524–524)
- Recalls: 2 (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)
- 2001: 3
- 2002: 1
- 2003: 1
- 2004: 1
- 2006: 1
- 2007: 1
- 2008: 1
- 2011: 1
- 2014: 1
- 2022: 1

## Most-cited predicates
- K954000: Roche Reagent for Bun (1995), cited by 4
- K971477: Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST) (1997), cited by 3
- K070146: Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP (2007), cited by 2
- K771923: Fastchem Bun (1977), cited by 2
- K944250: Urea Nitrogen Reagent (1995), cited by 1
- K011596: Urea Nitrogen (Bun) Liquid Reagent (2001), cited by 1
- K981918: UREA (1998), cited by 1
- K981106: Urea Nitrogen (Bun) Liquid Reagent (1998), cited by 1
- K880078: Urea Nitrogen (Bun) (1988), cited by 1

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