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510(k) Data Aggregation

    K Number
    K982121
    Device Name
    ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
    Manufacturer
    TRACE SCIENTIFIC LTD.
    Date Cleared
    1998-09-17

    (93 days)

    Product Code
    DBM
    Regulation Number
    866.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRACE SCIENTIFIC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the in vitro determination of mitochondrial (M2) antibody in human serum. Anti-M2 assays are used as an aid in the diagnosis of Primary Biliary Cirrhosis - CFR 866.5090
    Device Description
    Not Found
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    K Number
    K981123
    Device Name
    UREA
    Manufacturer
    TRACE SCIENTIFIC LTD.
    Date Cleared
    1998-04-24

    (28 days)

    Product Code
    CDQ
    Regulation Number
    862.1770
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRACE SCIENTIFIC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Urea Nitrogen assay is used for the quantitation of urea nitrogen in human serum, plasma, or urine. Measurements obtained by this device are used in diagnosis and treatment of certain renal and metabolic diseases.
    Device Description
    Urea Nitrogen is an in vitro diagnostic assay for the quantitative determination of urea nitrogen in human serum, plasma, or urine. The Urea Nitrogen assay is a clinical chemistry assay in which the the urea in the sample is hydrolyzed by urease to ammonia (NH3) and carbon dioxide (CO2). A second reaction, catalyzed by glutamate dehydrogenase (GLD), converts ammonia and a-ketoglutarate to glutamate and water with the concurrent oxidation of reduced nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine dinucleotide (NAD). Two moles of NADH are oxidized for each mole of urea present. The initial rate of decrease in absorbance at 340 nm is proportional to the urea concentration in the sample.
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    K Number
    K962890
    Device Name
    CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)
    Manufacturer
    TRACE SCIENTIFIC LTD.
    Date Cleared
    1996-09-27

    (65 days)

    Product Code
    CHH
    Regulation Number
    862.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRACE SCIENTIFIC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961114
    Device Name
    AST INCORPORATING DST
    Manufacturer
    TRACE SCIENTIFIC LTD.
    Date Cleared
    1996-05-23

    (64 days)

    Product Code
    CIT
    Regulation Number
    862.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRACE SCIENTIFIC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961123
    Device Name
    ALT INCORPORATING DST
    Manufacturer
    TRACE SCIENTIFIC LTD.
    Date Cleared
    1996-04-25

    (35 days)

    Product Code
    CKA
    Regulation Number
    862.1030
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRACE SCIENTIFIC LTD.

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