PER

Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

Product code

PER

Device name

Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

Device class

Class 1

21 CFR

21 CFR 862.2750

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).