Tq-Prep Workstation, Prepplus 2 Workstation

Q: What is the product code of K130253?

The FDA product code is PER – Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis, a Class I (low risk) device regulated under 21 CFR 862.2750.

FDA 510(k) K130253 · Beckman Coulter, Inc.

Substantially Equivalent

510(k) numberK130253

Submission

Device name: Tq-Prep Workstation, Prepplus 2 Workstation
Applicant: Beckman Coulter, Inc.
Miami, FL, US
Received: February 1, 2013
Decision date: July 15, 2013
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PER – Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Device class: Class I (low risk)
Regulation: 21 CFR 862.2750
Specialty: Clinical Chemistry

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.

Other 510(k)s with product code PER

510(k)	Device	Applicant	Decision
K131301	BD Facs Sample Prep Assistant IIIPER · Traditional	Becton, Dickinson & CO	08/02/2013SE
K050191	Modification to BD Facscanto System with BD Facscanto Clinical SoftwarePER · Special	Becton, Dickinson & CO	02/22/2005SE

More from Becton, Dickinson & CO

510(k)	Device	Decision
K252169	Access BNP IINBC · Traditional	03/24/2026SE
K254059	Access anti-HBc IgMSEI · Traditional	03/13/2026SE
K253687	Access anti-HBc TotalSEI · Traditional	02/19/2026SE
K251995	Access anti-HAV IgMLOL · Traditional	01/27/2026SE
K250588	Access Rubella IgGLFX · Traditional	11/17/2025SE
K252580	iQ200 SeriesLKM · Special	09/10/2025SE
K243846	Access anti-HAVLOL · Traditional	09/09/2025SE
K243804	MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional	08/20/2025SE
K250036	MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional	08/15/2025SE
K243483	Access hsTnIMMI · Traditional	08/01/2025SE

Questions and answers

When was Tq-Prep Workstation, Prepplus 2 Workstation cleared by the FDA?

Tq-Prep Workstation, Prepplus 2 Workstation (K130253) received a 510(k) decision of Substantially Equivalent on July 15, 2013, 164 days after the submission was received.

What is the product code of K130253?

The FDA product code is PER – Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis, a Class I (low risk) device regulated under 21 CFR 862.2750.