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    K Number
    K050338
    Device Name
    MODIFICATION TO: INSTAREAD LITHIUM SYSTEM
    Manufacturer
    Akers Biosciences, Inc.
    Date Cleared
    2005-03-04

    (21 days)

    Product Code
    JIH
    Regulation Number
    862.3560
    Why did this record match?
    Product Code :

    JIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InstaRead™ Lithium System is intended to measure lithium blood levels in whole blood (fingerstick or venous). Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).
    Device Description
    Not Found
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    K Number
    K031579
    Device Name
    INSTAREAD LITHIUM SYSTEM
    Manufacturer
    AKERS LABORATORIES, INC.
    Date Cleared
    2003-12-19

    (213 days)

    Product Code
    JIH
    Regulation Number
    862.3560
    Why did this record match?
    Product Code :

    JIH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InstaRead™ Lithium System is intended to measure lithium blood levels. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). The test is targeted for physician's office use, and may be used with whole blood, serum, or EDTA-plasma.
    Device Description
    The InstaRead™ Lithium System is an in vitro diagnostic device designed to provide accurate and precise measures of patient lithium blood levels using serum or whole blood specimens in an easy to use system that can be utilized at the point of care by non-clinical laboratory personnel. The system consists of three key components: Blood Cell Separator, Lithium Reagent, and InstaRead™ Lithium System photometric reader.
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    K Number
    K011033
    Device Name
    DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2001-06-07

    (63 days)

    Product Code
    JIH
    Regulation Number
    862.3560
    Why did this record match?
    Product Code :

    JIH

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