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

    CHEM-STRATE AMYLASE

    K Number: K792479 · Decision Dec 27, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    30
    Applicant Total
    39
    Review Days
    24

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    Basic Information

    Device Name
    CHEM-STRATE AMYLASE
    K Number
    K792479
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    General Diagnostics
    Date Received
    December 3, 1979
    Decision Date
    December 27, 1979
    Product Code
    CIJ
    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
    CIJ Saccharogenic, Amylase

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