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

    PERKIN ELMER MODEL 91 AMYLASE REAGENT

    K Number: K801096 · Decision Jun 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    31

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    Basic Information

    Device Name
    PERKIN ELMER MODEL 91 AMYLASE REAGENT
    K Number
    K801096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Stat Engineering
    Date Received
    May 9, 1980
    Decision Date
    June 9, 1980
    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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