Documento fuente o registro público
FDA 510(k) K230890 — ISE Electrodes
FDA 510(k) index record K230890. Device: ISE Electrodes. Applicant as listed: Randox Laboratories, Ltd.. Decision date: 2023-09-08.
Fuente
"device_name": "ISE Electrodes"
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2026-10-20
2026-10-28
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FDA 510(k) public index record K230890.
Device name: ISE Electrodes. Applicant as listed: Randox Laboratories, Ltd..
Decision date: 2023-09-08. Decision wording: Substantially Equivalent.
Product code: CEM. Regulation: 21 CFR 862.1600. 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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