Cleared Traditional

PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT

K050119 · Beckman Coulter, Inc. · Immunology

May 2005

Decision

108d

Days

Class 2

Risk

About This 510(k) Submission

K050119 is an FDA 510(k) clearance for the PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT, a Immunochemical, Bence-jones Protein (Class II — Special Controls, product code JKM), submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on May 6, 2005, 108 days after receiving the submission on January 18, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5150.

Submission Details

510(k) Number	K050119 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 2005
Decision Date	May 06, 2005
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF