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510(k) Data Aggregation

    K Number
    K100307
    Device Name
    GELSCAN, MODEL 1206
    Manufacturer
    SEBIA
    Date Cleared
    2010-08-31

    (209 days)

    Product Code
    CFE, CIN, JHY, JQT
    Regulation Number
    862.1445
    Why did this record match?
    Product Code :

    CFE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K022455
    Device Name
    SPIFE LD-12 KIT, MODEL 3338
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2002-10-01

    (67 days)

    Product Code
    CFE
    Regulation Number
    862.1445
    Why did this record match?
    Product Code :

    CFE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPIFE LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause. The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion. Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.
    Device Description
    Not Found
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    K Number
    K020467
    Device Name
    SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2002-03-29

    (45 days)

    Product Code
    CFE
    Regulation Number
    862.1445
    Why did this record match?
    Product Code :

    CFE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPIFE LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause. The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion. Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.
    Device Description
    Not Found
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    K Number
    K970477
    Device Name
    HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT
    Manufacturer
    SEBIA
    Date Cleared
    1997-03-10

    (31 days)

    Product Code
    CFE
    Regulation Number
    862.1445
    Why did this record match?
    Product Code :

    CFE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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