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510(k) Data Aggregation

    K Number
    K993276
    Device Name
    SIMPLIFY D-DIMER, MODEL DCGK1
    Manufacturer
    AGEN BIOMEDICAL LTD.
    Date Cleared
    1999-12-14

    (75 days)

    Product Code
    GHH
    Regulation Number
    864.7320
    Why did this record match?
    Applicant Name (Manufacturer) :

    AGEN BIOMEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma. The test is intended for use as an aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis and pulmonary embolism.
    Device Description
    The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma.
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    K Number
    K974596
    Device Name
    DIMERTEST LATEX ASSAY
    Manufacturer
    AGEN BIOMEDICAL LTD.
    Date Cleared
    1998-05-26

    (168 days)

    Product Code
    DAP
    Regulation Number
    864.7320
    Why did this record match?
    Applicant Name (Manufacturer) :

    AGEN BIOMEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dimertest Latex Assay is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin in human plasma.
    Device Description
    Not Found
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