BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    DC-UIBC-CAL

    K Number: K163078 · Decision Dec 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    244
    Applicant Total
    6
    Review Days
    35

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    Basic Information

    Device Name
    DC-UIBC-CAL
    K Number
    K163078
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sekisui Diagnostics P.E.I., Inc.
    Date Received
    November 3, 2016
    Decision Date
    December 8, 2016
    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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