Source document or public record
FDA 510(k) K232404 — CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
FDA 510(k) index record K232404. Device: CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES. Applicant as listed: Medicon Hellas S.A. Decision date: 2024-08-09.
Source
"device_name": "CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K232404.
Device name: CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES. Applicant as listed: Medicon Hellas S.A.
Decision date: 2024-08-09. Decision wording: Substantially Equivalent.
Product code: CHH. Regulation: 21 CFR 862.1175. 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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