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

    AMYLASE REAGENT KIT

    K Number: K812447 · Decision Sep 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    16
    Review Days
    12

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    Basic Information

    Device Name
    AMYLASE REAGENT KIT
    K Number
    K812447
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bioscientific
    Date Received
    August 28, 1981
    Decision Date
    September 9, 1981
    Product Code
    KHM
    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
    KHM Nephelometric, Amylase

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