Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS— 510(k) K161854

Name: FDA 510(k) clearance K161854
Creator: U.S. Food and Drug Administration
Published: 2016-10-04

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K161854 for Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS, Substantially Equivalent on 2016-10-04. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code PCN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2016-07-06
Decision date: 2016-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edgbaston, GB

Download summary PDF View on FDA.gov ↗

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