# JMT: Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)

- Device class: 1; regulation: 21 CFR 862.1510; FDA's rule: 510(k) exempt
- FDA decisions: 13
- 510(k) review time 2021–2025: median 119 days (middle half 96–157)
- 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)
- 1984: 1
- 1986: 1
- 1988: 1
- 1996: 3
- 1999: 1
- 2000: 1
- 2011: 1
- 2017: 1
- 2025: 3

## Most-cited predicates
- K100024: Teco Diagnostics Uti Detection Strips (2011), cited by 1
- K993850: Urinalysis Reagent Strips (10 Parameters) (2000), cited by 1

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