Source document or public record
FDA 510(k) K240865 — IDS-iSYS Free Testosterone
FDA 510(k) index record K240865. Device: IDS-iSYS Free Testosterone. Applicant as listed: Immunodiagnostic Systems Limited. Decision date: 2024-10-23.
Source
"device_name": "IDS-iSYS Free Testosterone"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K240865.
Device name: IDS-iSYS Free Testosterone. Applicant as listed: Immunodiagnostic Systems Limited.
Decision date: 2024-10-23. Decision wording: Substantially Equivalent.
Product code: CDZ. Regulation: 21 CFR 862.1680. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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