Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit

FDA 510(k) K172613 · The Binding Site Group , Ltd.

Substantially Equivalent

510(k) numberK172613

Submission

Device name
Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
Applicant
The Binding Site Group , Ltd.
Birmingham, GB
Received
August 31, 2017
Decision date
February 15, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PCN – Immunoglobulin G Kappa Heavy And Light Chain Combined
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Specialty
Immunology

Intended for the in-vitro quantification of IgG kappa concentration in human serum.

Other 510(k)s with product code PCN

510(k)DeviceApplicantDecision
K161854Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for…PCN · Traditional The Binding Site Group , Ltd.10/04/2016SE
K132555Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda KitPCN · Traditional The Binding Site12/20/2013SE

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Questions and answers

When was Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit cleared by the FDA?

Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit (K172613) received a 510(k) decision of Substantially Equivalent on February 15, 2018, 168 days after the submission was received.

What is the product code of K172613?

The FDA product code is PCN – Immunoglobulin G Kappa Heavy And Light Chain Combined, a Class II (moderate risk) device regulated under 21 CFR 866.5510.