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

    ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR

    K Number: K021535 · Decision Jun 27, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    244
    Applicant Total
    32
    Review Days
    48

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    Basic Information

    Device Name
    ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR
    K Number
    K021535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bayer Diagnostics Corp.
    Date Received
    May 10, 2002
    Decision Date
    June 27, 2002
    Product Code
    JIT
    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
    JIT Calibrator, Secondary

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