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510(k) Data Aggregation

    K Number
    K974909
    Device Name
    SYNERMED CREATININE REAGENT KIT
    Manufacturer
    SYNERMED INTL., INC.
    Date Cleared
    1998-02-24

    (55 days)

    Product Code
    CGX
    Regulation Number
    862.1225
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Synermed® Creatinine reagent is intended for use in the quantitative determination of creatinine in serum by manual and automated methods.

    Device Description

    Creatinine Reagent kit

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a Creatinine Reagent kit, indicating that the device is substantially equivalent to a predicate device. It defines the "Indications For Use" but does not detail acceptance criteria, study methods, sample sizes, or expert qualifications beyond stating the intended use of the reagent.

    Therefore, I cannot generate the requested table and paragraphs based on the input.

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