# DIH: Colorimetry, Cholinesterase

- Device class: 1; regulation: 21 CFR 862.3240; FDA's rule: 510(k) exempt
- FDA decisions: 26
- Recalls: 1 (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)
- 1988: 1
- 1989: 5
- 1991: 4
- 1996: 3
- 2000: 2
- 2002: 1
- 2003: 2
- 2005: 1
- 2006: 1
- 2011: 1

## Most-cited predicates
- K913198: Kodak Ektachem DT Slides (Che) (1991), cited by 1
- K912217: Kodak Ektachem Clinical Chemistry Slides (1991), cited by 1
- K030045: Olympus Cholinesterase Reagent (Catalog Number OSR6114) (2003), cited by 1
- K943367: IL Test Cholinesterase (1996), cited by 1

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