# CHI: Lipase-Esterase, Enzymatic, Photometric, Lipase

- Device class: 1; regulation: 21 CFR 862.1465; FDA's rule: 510(k) exempt
- FDA decisions: 20
- Recalls: 14 (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
- 1986: 1
- 1987: 1
- 1988: 3
- 1990: 2
- 1992: 2
- 1994: 2
- 1995: 3
- 1996: 1
- 1997: 1

## Most-cited predicates
- K952180: CX Lipase Reagent & Calibrator for Synchron CX Systems (1995), cited by 1
- K952647: IL Test Lipase (1995), cited by 1

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