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510(k) K972591

Device
HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT
Applicant
MORAX
510(k) number
K972591
Product code
JKM  
Decision
Substantially Equivalent (SESE)
Decision date
1998-03-04
Date received
1997-07-11
Regulation
866.5150
Classification name
Immunochemical, Bence-jones Protein
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BOREK JANIK
Address
13805 Waterloo Rd. Chelsea MI US 48118 48118

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K050119PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KITBeckman Coulter, Inc.2005-05-06

Legacy Summary#

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FDA Review#

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