FDA.report

510(k) K140105

Device
HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
Applicant
THE BINDING SITE
510(k) number
K140105
Product code
OPX  
Decision
Substantially Equivalent (SESE)
Decision date
2014-03-18
Date received
2014-01-15
Regulation
866.5510
Classification name
Immunoglobulin A Kappa Heavy & Light Chain Combined
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
Paul Kenny
Address
8 Calthorpe Rd. Birmingham GB B15 1QT B15 1QT

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Related GUDID Devices

Primary DIBrandCompanyPublished
05051700016926Hevylite IgA Lambda Kit for Siemens BNIITHE BINDING SITE GROUP LIMITED2016-09-24
05051700016919Hevylite® Human IgA Kappa Kit for use on the SiemeTHE BINDING SITE GROUP LIMITED2016-09-24

Other 510(k) Records For Product Code OPX  

510(k)DeviceApplicantDecision date
K160819Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda KitThe Binding Site Group , Ltd.2016-06-16
K151759Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUSThe Binding Site Group , Ltd.2015-11-06

Legacy Summary

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FDA Review

Decision Summary