510(k) K152389

Device: Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
Applicant: THE BINDING SITE GROUP LTD
510(k) number: K152389
Product code: PDE
Decision: Substantially Equivalent (SESE)
Decision date: 2015-12-18
Date received: 2015-08-24
Regulation: 866.5510
Classification name: Immunoglobulin M Kappa Heavy And Light Chain Combined
Medical specialty: Immunology
Review panel: Immunology
Device class: 2
Clearance type: Traditional
Statement or summary: Statement
Third party reviewed: No

Applicant Contact#

Contact: STEPHANIE THOULESS
Address: 8 Calthorpe Rd. Birmingham GB B15 1QT B15 1QT

FDA Registration Numbers#

9614373
3012471076

Source Documents#

510(k) summary PDF not indicated by FDA

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
05051700018364	Optilite Hevylite® IgM Lambda Kit	THE BINDING SITE GROUP LIMITED	2016-09-24
05051700018357	Optilite Hevylite® IgM Kappa Kit	THE BINDING SITE GROUP LIMITED	2016-09-24

Other 510(k) Records For Product Code PDE #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K140686	HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS	The Binding Site Group , Ltd.	2014-08-06

Legacy Summary#

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FDA Review#

Decision Summary