510(k) K252728— IDS-iSYS Total Testosterone

Substantially Equivalent

Immunodiagnostic Systems Limited

Clearance details

Applicant: Immunodiagnostic Systems Limited
Product code: Code CDZ
Advisory panel: Clinical Chemistry
Date received: 2025-08-28
Decision date: 2026-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyne & Wear, GB

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