FDA.report

510(k) K172613

Device
Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
Applicant
The Binding Site Group Ltd.
510(k) number
K172613
Product code
PCN  
Decision
Substantially Equivalent (SESE)
Decision date
2018-02-15
Date received
2017-08-31
Regulation
866.5510
Classification name
Immunoglobulin G Kappa Heavy And Light Chain Combined
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Andrea Thomas
Address
8 Calthorpe Rd. Birmingham GB B15 1QT B15 1QT

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
05051700020121Optilite Hevylite IgG Lambda KitTHE BINDING SITE GROUP LIMITED2018-04-12
05051700020114Optilite Hevylite IgG Kappa Kit THE BINDING SITE GROUP LIMITED2018-04-12

Other 510(k) Records For Product Code PCN  

510(k)DeviceApplicantDecision date
K161854Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUSThe Binding Site Group , Ltd.2016-10-04
K132555HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KITThe Binding Site2013-12-20

Legacy Summary

summary

FDA Review

Decision Summary