Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit— 510(k) K231290

Name: FDA 510(k) clearance K231290
Creator: U.S. Food and Drug Administration
Published: 2024-01-24

Substantially Equivalent

The Binding Site, Ltd.

FDA 510(k) clearance K231290 for Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit, Substantially Equivalent on 2024-01-24. Applicant: The Binding Site, Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site, Ltd.
Product code: Code DFH
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 2023-05-04
Decision date: 2024-01-24
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.