HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT— 510(k) K132555

Name: FDA 510(k) clearance K132555
Creator: U.S. Food and Drug Administration
Published: 2013-12-20

Substantially Equivalent

The Binding Site

FDA 510(k) clearance K132555 for HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT, Substantially Equivalent on 2013-12-20. Applicant: The Binding Site. Device class: 2.

Clearance details

Applicant: The Binding Site
Product code: Code PCN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2013-08-14
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code PCN

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K172613 — Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit2018-02-15
K161854 — Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS2016-10-04

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K103824 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS2012-02-27
K100455 — SPAPLUS ANALYZER2010-09-03
K092450 — HUMAN IGD KIT FOR USE ON SPAPLUS2009-12-28
K072166 — CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER2008-01-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.