# CFE: Electrophoretic, Lactate Dehydrogenase Isoenzymes

- Device class: 2; regulation: 21 CFR 862.1445; FDA's rule: 510(k) exempt
- FDA decisions: 28
- Recalls: 0 (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: 4
- 1989: 2
- 1991: 1
- 1992: 1
- 1994: 1
- 1997: 1
- 2002: 2
- 2010: 1

## Most-cited predicates
- K894081: Rocho Isomune - LD (1989), cited by 1

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