BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    QUANTIMETRIX TOTAL CREATINE KINASE CONTROL

    K Number: K874302 · Decision Feb 2, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    96
    Applicant Total
    8
    Review Days
    105

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    Basic Information

    Device Name
    QUANTIMETRIX TOTAL CREATINE KINASE CONTROL
    K Number
    K874302
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Quantimetrix Medical Industries
    Date Received
    October 20, 1987
    Decision Date
    February 2, 1988
    Product Code
    JJT
    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
    JJT Enzyme Controls (Assayed And Unassayed)

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