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510(k) K252728

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2026
Date Received
August 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class
Class I
Regulation Number
862.1680
Review Panel
CH
Submission Type

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  • K201908 — LIAISON Testosterone xt (October 15, 2020)
  • K191350 — ACTIVE® Free Testosterone RIA (December 20, 2019)
  • K191533 — ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (August 28, 2019)
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  • K181017 — Free Testosterone AccuBind ELISA Test System (July 20, 2018)