BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇷 Greece

    CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES

    K Number: K232404 · Decision Aug 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    229
    Applicant Total
    3
    Review Days
    365

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    Basic Information

    Device Name
    CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
    K Number
    K232404
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1175
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medicon Hellas S.A
    Date Received
    August 10, 2023
    Decision Date
    August 9, 2024
    Product Code
    CHH
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CHH Enzymatic Esterase--Oxidase, Cholesterol

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    Other Clearances by Medicon Hellas S.A

    K Number Device Name
    K200898 Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
    K062746 FERRITIN-LATEX, MODELS 1418-2070, 1418-0279