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510(k) Data Aggregation

    K Number
    K033114
    Device Name
    KETOCHECKS
    Manufacturer
    NEO DIAGNOSTICS, INC
    Date Cleared
    2004-04-26

    (209 days)

    Product Code
    JIN
    Regulation Number
    862.1435
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEO DIAGNOSTICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neo Diagnostics KetoChecks is intended for the identification of ketones in urine and can be used in the diagnosis of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as Acetoacetic acid) and for monitoring patients on ketogenic diets and patients with diabetes. The test is indicated for use by professionals and for Over the Counter use by lay people.
    Device Description
    KetoChecks for Urinalysis is firm plastic strips to which a reagent area is affixed. Depending on the product being used, KetoChecks provides a test for Ketone (Acetoacetic acid) in Urine. Test results may provide information regarding the status of carbohydrate metabolism. Please refer to the outside box and bottle label for the specific test parameters of the product you are using. KetoChecks is packaged along with a drying agent in a plastic bottle with a twist-off cap. Each strip is stable and ready to use upon removal from the bottle. The entire reagent strip is disposable. The directions must be followed exactly. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. Accurate timing is essential to provide optimal results. To obtain optimal results, it is necessary to use fresh, well-mixed, and uncentrifuged urine. No calculations or laboratory instruments are needed.
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