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510(k) Data Aggregation

    K Number
    K081360
    Device Name
    PATHFAST CK-MB-II, PATHFAST MYO-II
    Manufacturer
    MITSUBISHI KAGAKU IATRON
    Date Cleared
    2009-08-17

    (459 days)

    Product Code
    JHX, DDR, JIT
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITSUBISHI KAGAKU IATRON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PATHFAST CK-MB-II test is an in vitro diagnostic test for the quantitative measurement of creatine kinase-MB in heparinized or EDTA whole blood and plasma. Measurements of CK-MB are used in the aid of diagnosis of acute myocardial infarction. This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators. PATHFAST Myo-II test is an in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized or EDTA whole blood and plasma. Measurements of myoglobin are used to assist in the aid of diagnosis of myocardial infarction (MI). This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators.
    Device Description
    Not Found
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    K Number
    K072288
    Device Name
    PATHFAST D-DIMER
    Manufacturer
    MITSUBISHI KAGAKU IATRON
    Date Cleared
    2009-05-06

    (629 days)

    Product Code
    GHH
    Regulation Number
    864.7320
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITSUBISHI KAGAKU IATRON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K083412
    Device Name
    PATHFAST HSCRP
    Manufacturer
    MITSUBISHI KAGAKU IATRON
    Date Cleared
    2009-03-09

    (111 days)

    Product Code
    DCN, JIT
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITSUBISHI KAGAKU IATRON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PATHFAST® hsCRP test, for use with PATHFAST® analyzer, is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in heparinized or EDTA whole blood, plasma, and serum, as an aid in the detection and evaluation of the infection, tissue injury, inflammatory disorders, and associated disorders. This method is for use in clinical laboratory or point of care (POC) settings. PATHFAST® hsCRP Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the PATHFAST® System.
    Device Description
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    K Number
    K072189
    Device Name
    PATHFAST NTPROBNP AND D-DIMER TESTS
    Manufacturer
    MITSUBISHI KAGAKU IATRON
    Date Cleared
    2008-02-05

    (183 days)

    Product Code
    NBC
    Regulation Number
    862.1117
    Why did this record match?
    Applicant Name (Manufacturer) :

    MITSUBISHI KAGAKU IATRON

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