Product code
PER: Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis
FDA product code · Class I · Clinical Chemistry
Key facts
| Product code | PER |
|---|---|
| Device | Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis |
| Device class | Class I |
| Regulation number | 862.2750 |
| Review panel | Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- 10–99 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database