510(k) K252728

IDS-iSYS Total Testosterone by Immunodiagnostic Systems Limited — Product Code CDZ

K252728 is an FDA 510(k) premarket notification submitted by Immunodiagnostic Systems Limited for the device "IDS-iSYS Total Testosterone". The FDA issued a decision of Substantially Equivalent on April 15, 2026. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Immunodiagnostic Systems Limited has at least 2 other 510(k) clearances on record.