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    K Number
    K033297
    Device Name
    ZAP HCG TEST, MODEL 8001
    Manufacturer
    ZBX CORPORATION
    Date Cleared
    2004-03-18

    (156 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZBX CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ZAP™ hCG Test is an immunoassay used for the qualitative detection of human chorionic gonadotropin in human serum, plasma or whole blood and is indicated as an aid for health care professionals in the diagnosis of early pregnancy.
    Device Description
    The ZAP™ hCG Test is a one-step immunochromatographic assay for the rapid qualitative detection of hCG in human serum, plasma or whole blood.
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