# CFH: Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase

- Device class: 2; regulation: 21 CFR 862.1440; FDA's rule: 510(k) exempt
- FDA decisions: 13
- 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)
- 1979: 1
- 1981: 1
- 1982: 1
- 1984: 1
- 1985: 1
- 1986: 1
- 1988: 1
- 1989: 2
- 2002: 1
- 2005: 1

## Most-cited predicates

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