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    K Number
    K060853
    Device Name
    ONLINE TDM TOBRAMYCIN
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2006-06-09

    (72 days)

    Product Code
    KLB
    Regulation Number
    862.3900
    Why did this record match?
    Product Code :

    KLB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ONLINE TDM Tobramycin assay is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in human plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
    Device Description
    The ONLINE TDM Tobramycin assay is for the quantitative determination of tobramycin in human serum or plasma on Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Tobramycin reagent kits.
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    K Number
    K012312
    Device Name
    IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Date Cleared
    2001-08-20

    (28 days)

    Product Code
    KLB
    Regulation Number
    862.3900
    Why did this record match?
    Product Code :

    KLB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use with the IMMULITE 2000 Analyzer – for the quantitative measurement of tobramycin in serum or plasma, as an aid in monitoring the therapeutic administration of this aminoglycoside.
    Device Description
    IMMULITE® 2000 Tobramycin is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE® 2000 Automated Analyzer.
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    K Number
    K003341
    Device Name
    EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
    Manufacturer
    SYVA CO., DADE BEHRING, INC.
    Date Cleared
    2001-01-22

    (89 days)

    Product Code
    KLB, DLJ, LDO
    Regulation Number
    862.3900
    Why did this record match?
    Product Code :

    KLB

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