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510(k) Data Aggregation

    K Number
    K023396
    Device Name
    AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    2002-12-23

    (75 days)

    Product Code
    CIJ
    Regulation Number
    862.1070
    Why did this record match?
    Product Code :

    CIJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of amylase in human serum. It is intended for in vitro diagnostic use only. The determination of amylase in serum is most commonly performed for the diagnosis and treatment of diseases of the pancreas.
    Device Description
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    K Number
    K991817
    Device Name
    ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
    Manufacturer
    BAYER CORP.
    Date Cleared
    1999-07-22

    (56 days)

    Product Code
    CIJ
    Regulation Number
    862.1070
    Why did this record match?
    Product Code :

    CIJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bayer ADVIA IMS Amylase assay is an in vitro diagnostic device intended to measure amylase activity in human serum, plasma or urine. Such measurements are used as an aid primarily in the diagnosis and treatment of pancreatitis (inflammation of the pancreas). The Bayer ADVIA IMS Cortisol assay is an in vitro diagnostic device intended to quantitatively measure cortisol in human serum. Measurements of cortisol are used as an aid in the diagnosis and treatment of disorders of the adrenal gland. The Bayer ADVIA IMS Iron assay is an in vitro diagnostic device intended to measure iron in human serum of plasma. Measurements of iron are used as an aid in the diagnosis, monitoring and treatment of a variety of diseases including iron deficiency anemias, hemochromatosis, hemosiderosis from excessive iron intake, and hemolytic anemias. The Baver ADVIA IMS Thyroxine assay is an in vitro diagnostic device intended to measure thyroxine (T4), both protein bound and free, in human serum and plasma. Measurements of T4 are used as an aid in the diagnosis and treatment of thyroid diseases. The Baver ADVIA IMS Free Thyroxine (FT4) assay is an in vitro diagnostic device intended to quantitatively measure free thyroxine in human serum. Measurements of free thyroxine in conjunction with other thyroid tests and clinical indicators are used as an aid in the diagnostic discrimination and assessment of thyroid diseases. The Bayer ADVIA IMS Triiodothyronine (T3) assay is an in vitro diagnostic device intended to quantitatively measure triiodothyronine (T3) in human serum. Measurements of triiodothyronine, in conjunction with other thyroid tests and clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases. The Bayer ADVIA IMS Free Triiodothyronine (FT3) assay is an in vitro diagnostic device intended to quantitatively measure free triiodothyronine in human serum. Measurements of free triodothyronine, in conjunction with other first-line thyroid tests such as Thyroid Stimulating Hormone (TSH) and Free Thyroxine (Free T4), as well as other clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases. The Bayer ADVIA IMS T Uptake (TUP) assay is an in vitro diagnostic device intended to quantitatively measure the total amount of available binding sites for thyroid hormone on the thyroxine-binding proteins, globulin, pre-albumin, and albumin in human serum. Measurements of T Uptake, in conjunction with other thyroid tests and clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases. The Bayer ADVIA IMS Urea Nitrogen (BUN) method is an in vitro diagnostic device intended to measure urea nitrogen in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of certain renal and metabolic diseases.
    Device Description
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    K Number
    K980013
    Device Name
    AMYLASE
    Manufacturer
    AC BIOCHEMICALS, INC.
    Date Cleared
    1998-02-04

    (33 days)

    Product Code
    CIJ
    Regulation Number
    862.1070
    Why did this record match?
    Product Code :

    CIJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amylase Reagent is to be used in the assessment of pancreatitis.
    Device Description
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    K Number
    K953211
    Device Name
    AMYLASE (ETHYLIDENE PNGPG7) KIT
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    1996-06-21

    (347 days)

    Product Code
    CIJ
    Regulation Number
    862.1070
    Why did this record match?
    Product Code :

    CIJ

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

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