Documento fuente o registro público
FDA 510(k) K211685 — Elecsys Testosterone II
FDA 510(k) index record K211685. Device: Elecsys Testosterone II. Applicant as listed: Roche Diagnostics. Decision date: 2022-05-06.
Fuente
"device_name": "Elecsys Testosterone II"
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Review and references
Automated FDA record verification
2026-10-20
2026-10-31
professional use
FDA 510(k) public index record K211685.
Device name: Elecsys Testosterone II. Applicant as listed: Roche Diagnostics.
Decision date: 2022-05-06. 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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