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510(k) Data Aggregation

    K Number
    K031445
    Device Name
    MAINLINE MAXIE HCG URINE PREGNANCY TEST
    Manufacturer
    MAINLINE TECHNOLOGY, INC.
    Date Cleared
    2003-07-01

    (55 days)

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

    MAINLINE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Mainline Maxie hCG-Urine is a one-step immunoassay for the rapid qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy at a cut off concentration of 20 mIU/ml. This kit is used to obtain a visual result and is intended for professional and laboratory use.
    Device Description
    Not Found
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