BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TESTOSTERONE RADIOIMMUNOASSAY KIT 125I

    K Number: K780792 · Decision Jun 13, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    88
    Applicant Total
    6
    Review Days
    29

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    Basic Information

    Device Name
    TESTOSTERONE RADIOIMMUNOASSAY KIT 125I
    K Number
    K780792
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1680
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    The Upjohn Co.
    Date Received
    May 15, 1978
    Decision Date
    June 13, 1978
    Product Code
    CDZ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

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