# DMT: Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

- Device class: 2; regulation: 21 CFR 862.3040; FDA's rule: 510(k) required
- FDA decisions: 8
- 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)
- 1980: 1
- 1981: 1
- 1984: 1
- 1987: 1
- 1993: 1
- 1994: 1
- 1997: 1
- 2000: 1

## Most-cited predicates
- K923783: Ethyl Alcohol Assay (1993), cited by 2

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