# CFJ: Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

- Device class: 2; regulation: 21 CFR 862.1440; FDA's rule: 510(k) exempt
- FDA decisions: 111
- Recalls: 2 (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)
- 1992: 4
- 1993: 2
- 1994: 1
- 1995: 2
- 1996: 1
- 1997: 4
- 1998: 1
- 2005: 1
- 2009: 1
- 2013: 1

## Most-cited predicates
- K780563: Single Vial Lactate (1978), cited by 1

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