510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050119Substantially Equivalent

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

Siemens Healthcare Diagnostics Inc., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050119 is the FDA 510(k) clearance record for PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT, a class II device, cleared for Beckman Coulter, Inc. on under FDA product code JKM (Immunochemical, Bence-Jones Protein). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K050119.

Clearance record

Decision date
Received
(108 days to decision)
Product code
JKM Immunochemical, Bence-Jones Protein
Regulation
21 CFR 866.5150
Device class
Class II
Review panel
Immunology
Applicant
Beckman Coulter, Inc. 200 S. Kraemer Blvd., Brea CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JKM

Trailing 12 months

FDA records hold no clearances under product code JKM in the trailing twelve months.

FDA records show no clearances under product code JKM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JKM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260