# JGY: Colorimetric Method, Triglycerides

- Device class: 1; regulation: 21 CFR 862.1705; FDA's rule: 510(k) exempt
- FDA decisions: 22
- 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)
- 1986: 1
- 1989: 2
- 1990: 2
- 1991: 1
- 1994: 2
- 1995: 1
- 1997: 1
- 2000: 2
- 2003: 1
- 2012: 1

## Most-cited predicates
- K000586: Bioscanner Triglycerides Test Strips (2000), cited by 2
- K991894: Bioscanner Triglycerides Test Strips (2000), cited by 2
- K023639: Piccolo Triglycerides Test System (2003), cited by 2

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