BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BAYER SPECIAL CHEMISTRY CALIBRATORS

    K Number: K033380 · Decision Dec 16, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    107
    Registration Numbers
    107
    Same Product Code
    301
    Applicant Total
    32
    Review Days
    55

    Basic Information

    Device Name
    BAYER SPECIAL CHEMISTRY CALIBRATORS
    K Number
    K033380
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BAYER DIAGNOSTICS CORP.
    Date Received
    October 22, 2003
    Decision Date
    December 16, 2003
    Product Code
    JIX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JIX Calibrator, Multi-Analyte Mixture

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