Source document or public record
FDA 510(k) K252728 — IDS-iSYS Total Testosterone
FDA 510(k) index record K252728. Device: IDS-iSYS Total Testosterone. Applicant as listed: Immunodiagnostic Systems Limited. Decision date: 2026-04-15.
Source
"device_name": "IDS-iSYS Total 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 K252728.
Device name: IDS-iSYS Total Testosterone. Applicant as listed: Immunodiagnostic Systems Limited.
Decision date: 2026-04-15. 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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.