Product code PCN

Device name: Immunoglobulin G Kappa Heavy And Light Chain Combined
Medical specialty: Immunology
Device class: 2
Regulation number: 866.5510
Review panel: IM
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Definition: Intended for the in-vitro quantification of IgG kappa concentration in human serum.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K172613	Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit	The Binding Site Group , Ltd.	2018-02-15
K161854	Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS	The Binding Site Group , Ltd.	2016-10-04
K132555	HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT	The Binding Site	2013-12-20

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
05051700020114	Optilite Hevylite IgG Kappa Kit	THE BINDING SITE GROUP LIMITED	2018-04-12
05051700019378	Hevylite Human IgG Kappa Kit for use on the SPAPLU	THE BINDING SITE GROUP LIMITED	2017-07-25
05051700016971	Hevylite IgG Kappa Kit for Siemens BNII	THE BINDING SITE GROUP LIMITED	2016-09-24

Related 510(k) Records#