BD Facs Sample Prep Assistant III

Q: What is the product code of K131301?

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) K131301 · Becton, Dickinson & CO

Substantially Equivalent

510(k) numberK131301

Submission

Device name: BD Facs Sample Prep Assistant III
Applicant: Becton, Dickinson & CO
San Jose, CA, US
Received: May 7, 2013
Decision date: August 2, 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
K130253	Tq-Prep Workstation, Prepplus 2 WorkstationPER · Traditional	Beckman Coulter, Inc.	07/15/2013SE
K050191	Modification to BD Facscanto System with BD Facscanto Clinical SoftwarePER · Special	Becton, Dickinson & CO	02/22/2005SE

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Questions and answers

When was BD Facs Sample Prep Assistant III cleared by the FDA?

BD Facs Sample Prep Assistant III (K131301) received a 510(k) decision of Substantially Equivalent on August 2, 2013, 87 days after the submission was received.

What is the product code of K131301?

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.