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

    ALP IFCC Gen.2

    K Number: K171080 · Decision May 10, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    123
    Applicant Total
    14
    Review Days
    29

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    Basic Information

    Device Name
    ALP IFCC Gen.2
    K Number
    K171080
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Operations (Rdo)
    Date Received
    April 11, 2017
    Decision Date
    May 10, 2017
    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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