# Flow Cytometry Calibrator
> **Product code: PDX** · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.5220
## Classification
- **FDA Product Code:** PDX
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 864.5220
- **Review panel:** IM
- **Medical specialty:** Hematology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PDX)
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