Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit— 510(k) K152389

Name: FDA 510(k) clearance K152389
Creator: U.S. Food and Drug Administration
Published: 2015-12-18

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K152389 for Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit, Substantially Equivalent on 2015-12-18. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code PDE
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2015-08-24
Decision date: 2015-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

Download summary PDF View on FDA.gov ↗

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