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510(k) K050119

Device
PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT
Applicant
BECKMAN COULTER, INC.
510(k) number
K050119
Product code
JKM  
Decision
Substantially Equivalent (SESE)
Decision date
2005-05-06
Date received
2005-01-18
Regulation
866.5150
Classification name
Immunochemical, Bence-jones Protein
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KIM WALKER
Address
200 S. Kraemer Blvd. P.O. Box 8000, M/S W-515 Brea CA US 92822 92822

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JKM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K080916CAPILLARYS URINESebia2008-07-01
K070486CAPILLARYS URINE (PN 2012)Sebia, Inc.2007-12-21
K972591HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KITMorax1998-03-04

Legacy Summary#

summary

FDA Review#

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