# Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
> **Product code: PER** · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.2750
## Classification
- **FDA Product Code:** PER
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 862.2750
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis.

## Market data
- **Cleared 510(k) submissions:** 3
- **Registered establishments:** 14
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PER)
---
*AI Analytics · CC0 1.0*