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    K Number
    K093939
    Device Name
    ADVIA CHEMISTRY SALICYLATE REAGENT
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Date Cleared
    2010-05-19

    (148 days)

    Product Code
    DKJ
    Regulation Number
    862.3830
    Why did this record match?
    Product Code :

    DKJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use in the quantitative determination of salicylate in human serum and plasma (lithium heparin) on the ADVIA 1650 Chemistry systems. Such measurements are used in the diagnosis of salicylate toxicity and overdose
    Device Description
    Not Found
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    K Number
    K042329
    Device Name
    SALICYLATE-SL ASSAY
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2004-12-27

    (122 days)

    Product Code
    DKJ
    Regulation Number
    862.3830
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    Product Code :

    DKJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diagnostic Chemicals Limited's Salicylate method is an in vitro diagnostic device intended to measure salicylate levels in human serum or plasma (Lithium heparin). intended to modellio balleyfato to the diagnosis of salicylate toxicity and overdose.
    Device Description
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    K Number
    K020794
    Device Name
    SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
    Manufacturer
    BAYER DIAGNOSTICS CORP.
    Date Cleared
    2002-07-11

    (122 days)

    Product Code
    DKJ
    Regulation Number
    862.3830
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    Product Code :

    DKJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bayer ADVIA IMS Salicylate method is an in vitro diagnostic device intended to measure salicylate levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of salicylate toxicity and overdose.
    Device Description
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    K Number
    K014173
    Device Name
    SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2002-02-15

    (57 days)

    Product Code
    DKJ
    Regulation Number
    862.3830
    Why did this record match?
    Product Code :

    DKJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Salicylate (SALY) Reagent, when used in conjunction with SYNCHRON® Systems Salicylate Calibrator, is intended for the quantitative determination of salicylate in serum and plasma on Beckman Coulter's SYNCHRON Systems by a colorimetric timed-endpoint method. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.
    Device Description
    The SYNCHRON System Salicylate (SALY) Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. The assay is intended for use in the quantitative determination of salicylate concentration in serum or plasma by a colorimetric timed-endpoint method. The reagent kit contains two 45-test cartridges and is packaged with the single-level calibrator.
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    K Number
    K011878
    Device Name
    EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
    Manufacturer
    SYVA CO.
    Date Cleared
    2001-08-13

    (59 days)

    Product Code
    DKJ, DLJ
    Regulation Number
    862.3830
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    Product Code :

    DKJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme immunoassay intended for use in the quantitative analysis of salicylic acid in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of salicylic acid overdose or in monitoring levels of salicylic acid to ensure appropriate therapy.
    Device Description
    The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme assay intended for use in quantitative analysis of Salicylic Acid in human serum or plasma.
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    K Number
    K981872
    Device Name
    SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    1998-06-29

    (32 days)

    Product Code
    DKJ
    Regulation Number
    862.3830
    Why did this record match?
    Product Code :

    DKJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of salicylate in serum. For IN VITRO diagnostic use.
    Device Description
    This enzymatic Salicylate Assay provides a rapid, specific and simplified method for salicylate determination. It is based on the action of salicylate hydroxylase on salicylate and NADH which results in a decrease in absorbance proportional to the amount of salicylate present. The test can be adapted to automated instruments resulting in rapid, accurate results required by physicians.
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    K Number
    K980032
    Device Name
    SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    1998-03-02

    (56 days)

    Product Code
    DKJ
    Regulation Number
    862.3830
    Why did this record match?
    Product Code :

    DKJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of salicylate in serum. For IN VITRO diagnostic use.
    Device Description
    This enzymatic Salicylate Assay provides a rapid, specific and simplified method for salicylate determination. It is based on the action of salicylate hydroxylase on salicylate and NADH which results in a decrease in absorbance proportional to the amount of salicylate present. The test can be adapted to automated instruments resulting in rapid, accurate results required by physicians.
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    K Number
    K964715
    Device Name
    PARAMAX SALICYLATE REAGENT
    Manufacturer
    DADE INTL., INC.
    Date Cleared
    1997-04-25

    (151 days)

    Product Code
    DKJ
    Regulation Number
    862.3830
    Why did this record match?
    Product Code :

    DKJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Paramax® Salicylate Reagent is intended for use as quantitative determination of salicylate in plasma and serum.
    Device Description
    The Paramax® Salicylate Reagent is based on colormetric methodology.
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    K Number
    K961131
    Device Name
    SALICYLATE ASSAY
    Manufacturer
    DIAGNOSTIC REAGENTS, INC.
    Date Cleared
    1996-04-29

    (39 days)

    Product Code
    DKJ
    Regulation Number
    862.3830
    Why did this record match?
    Product Code :

    DKJ

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