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510(k) Data Aggregation

    K Number
    K994189
    Device Name
    OLYMPUS CREATINE KINASE REAGENT OSR6179/6279
    Manufacturer
    OLYMPUS DIAGNOSTICA GMBH
    Date Cleared
    2000-01-20

    (38 days)

    Product Code
    CGS
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    OLYMPUS DIAGNOSTICA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olympus Creatine Kinase reagent is intended for use in Olympus automated clinical chemistry analyzers for the quantitative determination of creatine kinase activity in human serum. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle disease, such as progressive Duchenne-type muscular dystrophy.
    Device Description
    Not Found
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    K Number
    K984145
    Device Name
    OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT
    Manufacturer
    OLYMPUS DIAGNOSTICA GMBH
    Date Cleared
    1998-12-23

    (34 days)

    Product Code
    DDR
    Regulation Number
    866.5680
    Why did this record match?
    Applicant Name (Manufacturer) :

    OLYMPUS DIAGNOSTICA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olympus Myoglobin reagent is intended to be utilized for the quantitative determination of myoglobin in human serum on Olympus analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
    Device Description
    Not Found
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    K Number
    K981854
    Device Name
    OLYMPUS SERUM PROTEIN MULTICALIBRATOR,
    Manufacturer
    OLYMPUS DIAGNOSTICA GMBH
    Date Cleared
    1998-08-18

    (84 days)

    Product Code
    JIT
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    OLYMPUS DIAGNOSTICA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olympus Serum Protein Multicalibrator, catalog number ODR3023, is designed for use in Olympus automated clinical chemistry analyzers for α-1-acidoglycoprotein, α-1-antitrypsin, haptoglobin and ß-2-microglobulin determinations.
    Device Description
    Not Found
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    K Number
    K982035
    Device Name
    OLYMPUS CALCIUM ARSENAZO III REAGENT
    Manufacturer
    OLYMPUS DIAGNOSTICA GMBH
    Date Cleared
    1998-06-24

    (14 days)

    Product Code
    CJY
    Regulation Number
    862.1145
    Why did this record match?
    Applicant Name (Manufacturer) :

    OLYMPUS DIAGNOSTICA GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Olympus Calcium Arsenazo Reagent is intended for the quantitative determination of Calcium concentrations in human serum on Olympus clinical chemistry analyzers.
    Device Description
    Olympus Calcium Arsenazo Reagent
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