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

    RIA KIT, QUANTITATION OF PROSTATIC ACID

    K Number: K790817 · Decision May 7, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    44
    Applicant Total
    18
    Review Days
    10

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    Basic Information

    Device Name
    RIA KIT, QUANTITATION OF PROSTATIC ACID
    K Number
    K790817
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    New England Nuclear
    Date Received
    April 27, 1979
    Decision Date
    May 7, 1979
    Product Code
    JFH
    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
    JFH Acid Phosphatase (Prostatic), Tartrate Inhibited

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