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FDA 510(k)

CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES

K-Number: K232404 · 2024-08-09

ApplicantMedicon Hellas S.A
Decision Date2024-08-09
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES is a medical device manufactured by Medicon Hellas S.A. It received FDA 510(k) clearance on 2024-08-09 under approval number K232404. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES?

CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES is a medical device that received FDA 510(k) clearance on 2024-08-09. It is manufactured by Medicon Hellas S.A. The 510(k) number is K232404.

When was CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES approved by the FDA?

CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES received FDA 510(k) clearance on 2024-08-09, under approval number K232404.

What company makes CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES?

CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES is manufactured by Medicon Hellas S.A.

What is the FDA product code for CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES?

The FDA product code for CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES is CHH.

Other Devices by Medicon Hellas S.A

K200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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