# CKD: Hydrazone Colorimetry, Alt/Sgpt

- Device class: 1; regulation: 21 CFR 862.1030; FDA's rule: 510(k) exempt
- FDA decisions: 11
- 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)
- 1982: 2
- 1984: 2
- 1986: 2
- 1988: 2
- 1990: 1
- 1995: 1
- 1999: 1

## Most-cited predicates
- K864082: Reflotron (R) Alt (GPT) (1986), cited by 1

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