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

    QUICK-CHEM CALIBRATION SET

    K Number: K852260 · Decision Jul 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    16
    Applicant Total
    20
    Review Days
    59

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    Basic Information

    Device Name
    QUICK-CHEM CALIBRATION SET
    K Number
    K852260
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Seragen Diagnostics, Inc.
    Date Received
    May 24, 1985
    Decision Date
    July 22, 1985
    Product Code
    JIW
    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
    JIW Calibrator, Surrogate

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