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

    TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113

    K Number: K012518 · Decision Oct 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    123
    Applicant Total
    4
    Review Days
    64

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    Basic Information

    Device Name
    TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113
    K Number
    K012518
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermo Dma, Inc.
    Date Received
    August 6, 2001
    Decision Date
    October 9, 2001
    Product Code
    CJE
    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
    CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

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