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510(k) Data Aggregation

    K Number
    K042005
    Device Name
    ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
    Manufacturer
    TaiDoc Technology Corporation
    Date Cleared
    2004-08-27

    (32 days)

    Product Code
    NBW,CGA
    Regulation Number
    862.1345
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222

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

    The Achtung TD-4207 I Clever Chek TD-4209 / Clever Chek TD-4222 Glucose Test Systems are intended for use in the quantitative measurement of glucose in whole blood samples taken from the finger. They are intended for use by healthcare professionals and people with diabetes mellitus as an aid in monitoring the effectiveness of diabetes management. They are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is related to a 510(k) premarket notification for a Glucose Test System and does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. The document primarily focuses on the FDA's substantial equivalence determination for marketing the device.

    Therefore, I cannot provide the requested table and study details based on the given input.

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