PERClass I

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

21 CFR 862.2750 / Clinical Chemistry

PER is the FDA product code for Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis, a class I device type, regulated under 21 CFR 862.2750. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 2013-08-02, and 10 recalls.

Classification record

Product code: PER
Device name: Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
FDA 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.
Regulation: 21 CFR 862.2750
Device class: Class I
Review panel: Clinical Chemistry
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 3
Ingested recalls: 10

Clearances, product code PER

By decision year

3 clearances under product code PER with a decision year between 2005 and 2013, 2013 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code PER by decision year
Year	Clearances
2005	1
2013	2

Applicants with the most clearances

Product code PER

Applicants holding the most 510(k) clearances under product code PER
Applicant	Clearances
Becton Dickinson & Co	2
Siemens Healthcare Diagnostics Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order