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    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇷 Argentina

    WIENER LAB AMILASA 405 AA LIQUIDA

    K Number: K023549 · Decision Dec 9, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    98
    Applicant Total
    24
    Review Days
    48

    Basic Information

    Device Name
    WIENER LAB AMILASA 405 AA LIQUIDA
    K Number
    K023549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    WIENER LABORATORIES S.A.I.C.
    Date Received
    October 22, 2002
    Decision Date
    December 9, 2002
    Product Code
    JFJ
    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
    JFJ Catalytic Methods, Amylase

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