CHOLESTEROL; HDL-cholesterol; LDL-cholesterol; TRIGLYCERIDES— 510(k) K232404

Name: FDA 510(k) clearance K232404
Creator: U.S. Food and Drug Administration
Published: 2024-08-09

Substantially Equivalent

Medicon Hellas S.A

FDA 510(k) clearance K232404 for CHOLESTEROL; HDL-cholesterol; LDL-cholesterol; TRIGLYCERIDES, Substantially Equivalent on 2024-08-09. Applicant: Medicon Hellas S.A. Device class: 1.

Clearance details

Device name as filed: CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
Applicant: Medicon Hellas S.A
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2023-08-10
Decision date: 2024-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gerakas, GR

Download summary PDF View on FDA.gov ↗

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