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

    GENZYME DIRECT-AMYLASE TEST REAGENT

    K Number: K011843 · Decision Aug 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    27
    Review Days
    59

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    Basic Information

    Device Name
    GENZYME DIRECT-AMYLASE TEST REAGENT
    K Number
    K011843
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genzyme Corp.
    Date Received
    June 12, 2001
    Decision Date
    August 10, 2001
    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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