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510(k) Data Aggregation

    K Number
    K030430
    Device Name
    POLY STAT SERUM/URINE HCG TEST
    Manufacturer
    ALIDEX, INC.
    Date Cleared
    2003-04-18

    (67 days)

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

    ALIDEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.
    Device Description
    The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant.
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    K Number
    K021386
    Device Name
    POLY STAT HCG DIPSTICK TEST
    Manufacturer
    ALIDEX, INC.
    Date Cleared
    2002-08-05

    (95 days)

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

    ALIDEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Poly stat hCG Dipstick Test is intended to detect the presence of human chorionic gonadotrpin (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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