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510(k) K240865

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2024
Date Received
March 28, 2024
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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