IDS-iSYS Free Testosterone— 510(k) K240865

Name: FDA 510(k) clearance K240865
Creator: U.S. Food and Drug Administration
Published: 2024-10-23

Substantially Equivalent

Immunodiagnostic Systems Limited

FDA 510(k) clearance K240865 for IDS-iSYS Free Testosterone, Substantially Equivalent on 2024-10-23. Applicant: Immunodiagnostic Systems Limited. Device class: 1.

Clearance details

Applicant: Immunodiagnostic Systems Limited
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 2024-03-28
Decision date: 2024-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyne & Wear, 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.