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510(k) Data Aggregation

    K Number
    K063701
    Device Name
    TECO HOMOCYSTEINE ENZYMATIC ASSAY
    Manufacturer
    TECO DIAGNOSTICS
    Date Cleared
    2007-04-11

    (119 days)

    Product Code
    LPS
    Regulation Number
    862.1377
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Teco Enzymatic Homocysteine Assay is in vitro quantitative determination of total homocysteine in serum and plasma. Homocysteine measurements are used in the diagnostics and treatment of hyperhomocysteinemia.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document discusses regulatory approval for a medical device (Teco Enzymatic Homocysteine Assay) but does not include details about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment. It is a letter of substantial equivalence from the FDA, not a study report.

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