# JHY: Colorimetric Method, Cpk Or Isoenzymes

- Device class: 2; regulation: 21 CFR 862.1215; FDA's rule: 510(k) required
- FDA decisions: 40
- 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)
- 1992: 3
- 1993: 1
- 1995: 1
- 1996: 1
- 1997: 2
- 2002: 2
- 2007: 1
- 2013: 1
- 2014: 2
- 2015: 1

## Most-cited predicates
- K970343: MMB Method (1997), cited by 3
- K132571: Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB Immunoassay (2013), cited by 1
- K974421: Elecsys CK-MB Stat (1997), cited by 1
- K022654: Modification to Elecsys CK-MB Stat, Elecsys CK-MB (2002), cited by 1
- K931172: Imx (R) Stat CK-MB (1993), cited by 1

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