# DML: Nad-Nadh, Specific Reagent For Alcohol Enzyme Method

- Device class: 2; regulation: 21 CFR 862.3040; FDA's rule: 510(k) required
- FDA decisions: 13
- 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)
- 1984: 3
- 1986: 1
- 1987: 1
- 1988: 1
- 1991: 1
- 1993: 1
- 1995: 2
- 1996: 1
- 2000: 1
- 2001: 1

## Most-cited predicates
- K993980: Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409UL (2000), cited by 1

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