# CEN: Dye-Indicator, Ph (Urinary, Non-Quantitative)

- Device class: 1; regulation: 21 CFR 862.1550; FDA's rule: 510(k) exempt
- FDA decisions: 11
- Recalls: 4 (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)
- 1982: 1
- 1983: 3
- 1984: 1
- 1997: 1
- 2003: 1
- 2004: 1
- 2005: 1
- 2007: 1
- 2009: 1

## Most-cited predicates
- K962718: Femexam Testcard (1997), cited by 2
- K071100: Amniscreen Home Detection Liner Kit (2007), cited by 1

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