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510(k) Data Aggregation

    K Number
    K010790
    Device Name
    CORTISOL LIA
    Manufacturer
    KMI DIAGNOSTICS, INC.
    Date Cleared
    2002-01-29

    (320 days)

    Product Code
    CGR
    Regulation Number
    862.1205
    Why did this record match?
    Applicant Name (Manufacturer) :

    KMI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990073
    Device Name
    CALCITONIN
    Manufacturer
    KMI DIAGNOSTICS, INC.
    Date Cleared
    1999-05-11

    (120 days)

    Product Code
    JKR
    Regulation Number
    862.1140
    Why did this record match?
    Applicant Name (Manufacturer) :

    KMI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL Calcitonin Enzyme Immunoassay Kit provides materials intended to measure the thyroid calcitonin levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism. This assay is intended for in vitro diagnostic use only.
    Device Description
    Calcitonin ELISA Test Kit
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    K Number
    K973900
    Device Name
    TESTOTERONE ELISA
    Manufacturer
    KMI DIAGNOSTICS, INC.
    Date Cleared
    1998-02-24

    (133 days)

    Product Code
    CDZ
    Regulation Number
    862.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    KMI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL Testosterone assay is an Enzyme-Immunoassay (EIA) for the quantitative determination of Testosterone in human serum or plasma.
    Device Description
    Testosterone ELISA Test Kit
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    K Number
    K973901
    Device Name
    17 B-ESTRADIOL (ELISA)
    Manufacturer
    KMI DIAGNOSTICS, INC.
    Date Cleared
    1997-11-24

    (41 days)

    Product Code
    CHP
    Regulation Number
    862.1260
    Why did this record match?
    Applicant Name (Manufacturer) :

    KMI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL Estradiol ELISA test kit is intended for the in vitro determination of estradiol, an estrogenic steroid, in human serum and plasma. Estradiol measurements are used in the diagnostics and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
    Device Description
    Not Found
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    K Number
    K973897
    Device Name
    DHEA-S
    Manufacturer
    KMI DIAGNOSTICS, INC.
    Date Cleared
    1997-11-13

    (30 days)

    Product Code
    JKC
    Regulation Number
    862.1245
    Why did this record match?
    Applicant Name (Manufacturer) :

    KMI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL DHEA-S ELISA test kit is intended for the in vitro determination of DHEA-S (dehydroepiandrosterone sulphate) in human serum and plasma. DHEA measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.
    Device Description
    Not Found
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    K Number
    K973898
    Device Name
    PROGESTERONE ELISA
    Manufacturer
    KMI DIAGNOSTICS, INC.
    Date Cleared
    1997-11-13

    (30 days)

    Product Code
    JLS
    Regulation Number
    862.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    KMI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IBL Progesterone ELISA test kit is intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
    Device Description
    Not Found
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