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510(k) Data Aggregation

    K Number
    K033344
    Device Name
    LIGAND PLUS CONTROL LEVEL 1-3
    Manufacturer
    CONSOLIDATED TECHNOLOGY
    Date Cleared
    2004-01-16

    (88 days)

    Product Code
    JJY, DIF
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONSOLIDATED TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LIGAND PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and therapeutic drugs as listed in this package insert.
    Device Description
    LIGAND PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert. Human origin components are added to a human serum based matrix. The product contains <0.1% sodium azide. This product will be offered as an assayed or unassayed three level control.
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    K Number
    K023731
    Device Name
    QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3
    Manufacturer
    CONSOLIDATED TECHNOLOGY
    Date Cleared
    2002-12-24

    (48 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONSOLIDATED TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QUICKCHECK LIQUID CHEMISTRY CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze routine chemistry analytes as listed in this package insert.
    Device Description
    QUICKCHECK LIQUID CHEMISTRY CONTROL is designed to monitor the performance of test procedures that analyze a number of routine chemistry analytes as listed in the package insert. This product will be offered as an assayed and unassayed control. In addition, the control is being expanded to three levels.
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    K Number
    K020237
    Device Name
    IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3
    Manufacturer
    CONSOLIDATED TECHNOLOGY
    Date Cleared
    2002-03-19

    (55 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONSOLIDATED TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and theraputic drugs as listed in this package insert.
    Device Description
    IMMUNOASSAY PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert. Human origin components are added to a human serum based matrix. The product contains 0.1% sodium azide. IMMUNOASSAY PLUS CONTROL will be offered in three levels of 5.0 mL filled vials.
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    K Number
    K003716
    Device Name
    CONFORMANCE CHEMISTRY CONTROL C3
    Manufacturer
    CONSOLIDATED TECHNOLOGY
    Date Cleared
    2000-12-20

    (19 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONSOLIDATED TECHNOLOGY

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

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