# Colorimetric Method, Cpk Or Isoenzymes
> **Product code: JHY** · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1215
## Classification
- **FDA Product Code:** JHY
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.1215
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Market data
- **Cleared 510(k) submissions:** 40
- **Registered establishments:** 11
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=JHY)
---
*AI Analytics · CC0 1.0*