# LJX: Test, Urine Leukocyte

- Device class: 1; regulation: 21 CFR 864.7675; FDA's rule: 510(k) exempt
- FDA decisions: 7
- 510(k) review time 2021–2025: median 65 days (middle half 65–65)
- Recalls: 3 (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)
- 1985: 1
- 1987: 1
- 1997: 1
- 1998: 1
- 2000: 1
- 2007: 1
- 2023: 1

## Most-cited predicates
- K231045: Healgen URS Test Strips (2023), cited by 3
- K971976: Diascreen Reagent Strips (1997), cited by 2

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