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

    DART ALPHA-AMYLASE REAGENT SYSTEM

    K Number: K834053 · Decision Feb 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    30
    Applicant Total
    101
    Review Days
    73

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    Basic Information

    Device Name
    DART ALPHA-AMYLASE REAGENT SYSTEM
    K Number
    K834053
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Coulter Electronics, Inc.
    Date Received
    November 23, 1983
    Decision Date
    February 4, 1984
    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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