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510(k) Data Aggregation

    K Number
    K960183
    Device Name
    FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
    Manufacturer
    SMITH KLINE DIAGNOSTICS, INC.
    Date Cleared
    1996-06-07

    (143 days)

    Product Code
    LYR
    Regulation Number
    866.3110
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMITH KLINE DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FlexSure® HP test for IgG antibodies to H. pylori in whole blood is a rapid, visually read, qualitative immunochromatographic method. The test is for use by health professionals as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease.
    Device Description
    The FlexSure® HP test for IgG antibodies to H. pylori in whole blood is a rapid, visually read, qualitative immunochromatographic method.
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