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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 the device name listed in this FDA 510(k) record. The listed applicant is Medicon Hellas S.A. It received FDA 510(k) clearance on 2024-08-09 under 510(k) 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. The listed applicant is Medicon Hellas S.A. The 510(k) number is K232404.

When did CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES receive FDA 510(k) clearance?

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

Who is the listed applicant for CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES?

The FDA 510(k) record lists Medicon Hellas S.A as the applicant. This does not by itself establish the device manufacturer.

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.

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Other records listing Medicon Hellas S.A as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: CHH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251091LipidsTruvian HealthK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, Inc.K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc.

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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