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510(k) Data Aggregation

    K Number
    K112416
    Device Name
    CPK REAGENT
    Manufacturer
    VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD
    Date Cleared
    2011-11-09

    (79 days)

    Product Code
    CGS
    Regulation Number
    862.1215
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Vital Diagnostics CPK Reagent is a device intended for the in vitro quantitative determination of creatine phosphokinase activity in human serum or plasma. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

    Device Description

    Vital Diagnostics CPK Reagent

    AI/ML Overview

    The provided text is a 510(k) clearance letter for a medical device called "Vital Diagnostics CPK Reagent". It primarily focuses on the regulatory approval of the device and its indications for use. The document does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies.

    Therefore, I cannot populate the requested information. The document is strictly a regulatory approval letter.

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