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

    PROSTATIC ACID RADIOIMMUNOASSAY TEST

    K Number: K791497 · Decision Dec 4, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    44
    Applicant Total
    27
    Review Days
    123

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    Basic Information

    Device Name
    PROSTATIC ACID RADIOIMMUNOASSAY TEST
    K Number
    K791497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Clinical Assays, Inc.
    Date Received
    August 3, 1979
    Decision Date
    December 4, 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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