Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit— 510(k) K160819

Name: FDA 510(k) clearance K160819
Creator: U.S. Food and Drug Administration
Published: 2016-06-16

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K160819 for Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit, Substantially Equivalent on 2016-06-16. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code OPX
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2016-03-24
Decision date: 2016-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edgbaston, GB

Download summary PDF View on FDA.gov ↗

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