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510(k) Data Aggregation

    K Number
    K012559
    Device Name
    POLY STAT HCG TEST
    Manufacturer
    BION DIAGNOSTIC SCIENCES
    Date Cleared
    2001-10-16

    (69 days)

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

    BION DIAGNOSTIC SCIENCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Poly stat hCG Test is intended to detect the presence of human chorionic gonadotropin (hCG) in the urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.
    Device Description
    Not Found
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