# CDM: Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

- Device class: 1; regulation: 21 CFR 862.1785; FDA's rule: 510(k) exempt
- FDA decisions: 9
- Recalls: 0 (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)
- 1979: 1
- 1983: 3
- 1985: 1
- 1988: 2
- 2006: 2

## Most-cited predicates
- K052719: Uritest 10 Urinalysis Reagent Strips (2006), cited by 2

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