HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT— 510(k) K113823

Name: FDA 510(k) clearance K113823
Creator: U.S. Food and Drug Administration
Published: 2013-03-27

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K113823 for HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT, Substantially Equivalent on 2013-03-27. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2011-12-27
Decision date: 2013-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

Download summary PDF View on FDA.gov ↗

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