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510(k) Data Aggregation

    K Number
    K063744
    Device Name
    COBAS INTEGRA C 111
    Manufacturer
    ROCHDIAG
    Date Cleared
    2007-01-17

    (30 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROCHDIAG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In vitro test for the quantitative determination of total bilirubin in human serum and plasma on the cobas c 111 system. Measurements of the levels of bilirubin and organic compound formed during normal and abnormal destruction of red cells, is used in the diagnosis of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block.
    Device Description
    The Total Bilirubin Special reagent is intended for use on the cobas c 111 analyzer for the quantitative determination of total or direct bilirubin in serum and plasma. The cobas c 111 analyzer is a partially automated, in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride. The cobas c 111 instrument is a random access analyzer designed to be operated on a bench top in the professional environment using a combination of a photometric analysis unit and an optional ion selective electrodes (ISE).
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    K Number
    K011658
    Device Name
    CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS
    Manufacturer
    ROCHDIAG
    Date Cleared
    2001-07-31

    (63 days)

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

    ROCHDIAG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the calibration of Roche lipid methods on automated clinical chemistry analyzers.
    Device Description
    The Calibrator for Automated Systems (C.f.a.s.) consists of liquid human serum with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.
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    K Number
    K010978
    Device Name
    TINA-QUANT ALPHA-1 ANTITRYPSIN
    Manufacturer
    ROCHDIAG
    Date Cleared
    2001-05-18

    (66 days)

    Product Code
    DEM
    Regulation Number
    866.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROCHDIAG

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