Cleared Traditional

CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES

K232404 · Medicon Hellas S.A · Chemistry
Aug 2024
Decision
365d
Days
Class 1
Risk

About This 510(k) Submission

K232404 is an FDA 510(k) clearance for the CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Medicon Hellas S.A (Gerakas, GR). The FDA issued a Cleared decision on August 9, 2024, 365 days after receiving the submission on August 10, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K232404 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2023
Decision Date August 09, 2024
Days to Decision 365 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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