510(k) K050119

PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT by Beckman Coulter, Inc. — Product Code JKM

K050119 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT". The FDA issued a decision of Substantially Equivalent on May 6, 2005. The device falls under product code JKM (Immunochemical, Bence-Jones Protein), a Class II device regulated under 21 CFR 866.5150. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.