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510(k) Data Aggregation

    K Number
    K981512
    Device Name
    ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025
    Manufacturer
    SKD, INC. A BECKMAN COULTER CO.
    Date Cleared
    1998-05-28

    (30 days)

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

    SKD, INC. A BECKMAN COULTER CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ICON® Fx hCG test is a rapid qualitative test designed to detect human chorionic gonadotropin (hCG) in urine or serum, as an aid in the early detection of pregnancy. The ICON® Fx hCG test is for professional use.
    Device Description
    The ICON® Fx hCG test uses two distinct monoclonal antibodies specific to the alpha and beta subunits of hCG to provide a test capable of detecting hCG concentrations as low as 20 mIU/mL urine and 10 mIU/mL serum (IU=International Units).
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