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

    PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT

    K Number: K862483 · Decision Jan 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    88
    Applicant Total
    16
    Review Days
    198

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    Basic Information

    Device Name
    PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT
    K Number
    K862483
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1680
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Pantex, Div. Bio-Analysis, Inc.
    Date Received
    June 30, 1986
    Decision Date
    January 14, 1987
    Product Code
    CDZ
    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
    CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

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