Cleared Traditional

HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT

K132555 · The Binding Site · Immunology
Dec 2013
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K132555 is an FDA 510(k) clearance for the HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT, a Immunoglobulin G Kappa Heavy And Light Chain Combined (Class II — Special Controls, product code PCN), submitted by The Binding Site (Birmingham, GB). The FDA issued a Cleared decision on December 20, 2013, 128 days after receiving the submission on August 14, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K132555 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2013
Decision Date December 20, 2013
Days to Decision 128 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code PCN — Immunoglobulin G Kappa Heavy And Light Chain Combined
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510
Definition Intended For The In-vitro Quantification Of Igg Kappa Concentration In Human Serum.