Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by Subtraction Kit

Q: What is the product code of K050119?

The FDA product code is JKM – Immunochemical, Bence-Jones Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5150.

FDA 510(k) K050119 · Beckman Coulter, Inc.

Substantially Equivalent

510(k) numberK050119

Submission

Device name: Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by Subtraction Kit
Applicant: Beckman Coulter, Inc.
Brea, CA, US
Received: January 18, 2005
Decision date: May 6, 2005
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JKM – Immunochemical, Bence-Jones Protein
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5150
Specialty: Immunology

Other 510(k)s with product code JKM

510(k)	Device	Applicant	Decision
K080916	Capillarys UrineJKM · Special	Sebia	07/01/2008SE
K070486	Capillarys Urine (PN 2012)JKM · Traditional	Sebia, Inc.	12/21/2007SE
K972591	Hydragel Bence Jones Kit/Maxi Kit Hydragel Bence Jones/Hydragel 2/4 Bence Jones KitJKM · Traditional	Morax	03/04/1998SE

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Questions and answers

When was Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by Subtraction Kit cleared by the FDA?

Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by Subtraction Kit (K050119) received a 510(k) decision of Substantially Equivalent on May 6, 2005, 108 days after the submission was received.

What is the product code of K050119?

The FDA product code is JKM – Immunochemical, Bence-Jones Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5150.