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

    CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS

    K Number: K011658 · Decision Jul 31, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    301
    Applicant Total
    3
    Review Days
    63

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    Basic Information

    Device Name
    CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS
    K Number
    K011658
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rochdiag
    Date Received
    May 29, 2001
    Decision Date
    July 31, 2001
    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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