# JJB: Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)

- Device class: 1; regulation: 21 CFR 862.1115; FDA's rule: 510(k) exempt
- FDA decisions: 5
- 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)
- 1984: 1
- 1986: 1
- 1987: 1
- 1994: 1
- 1995: 1

## Most-cited predicates
- K943008: Bioscan Reagent Strips (1994), cited by 2

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