Modification to BD Facscanto System with BD Facscanto Clinical Software

Q: What is the product code of K050191?

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) K050191 · Becton, Dickinson & CO

Substantially Equivalent

510(k) numberK050191

Submission

Device name: Modification to BD Facscanto System with BD Facscanto Clinical Software
Applicant: Becton, Dickinson & CO
San Jose, CA, US
Received: January 27, 2005
Decision date: February 22, 2005
Decision: Substantially Equivalent (SESE)
Type: Special 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
K130253	Tq-Prep Workstation, Prepplus 2 WorkstationPER · Traditional	Beckman Coulter, Inc.	07/15/2013SE

More from Beckman Coulter, Inc.

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Questions and answers

When was Modification to BD Facscanto System with BD Facscanto Clinical Software cleared by the FDA?

Modification to BD Facscanto System with BD Facscanto Clinical Software (K050191) received a 510(k) decision of Substantially Equivalent on February 22, 2005, 26 days after the submission was received.

What is the product code of K050191?

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.