# Calibrator For Cell Indices
> **Product code: KRX** · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.8150
## Classification
- **FDA Product Code:** KRX
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 864.8150
- **Review panel:** HE
- **Medical specialty:** Hematology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Market data
- **Cleared 510(k) submissions:** 16
- **Registered establishments:** 15
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=KRX)
---
*AI Analytics · CC0 1.0*