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

    ANDROSTENEDIONE RADIOIMMUNOASSAY KIT

    K Number: K801729 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    9
    Applicant Total
    6
    Review Days
    99

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    Basic Information

    Device Name
    ANDROSTENEDIONE RADIOIMMUNOASSAY KIT
    K Number
    K801729
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1075
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diagnostics Biochem Canada, Inc.
    Date Received
    July 24, 1980
    Decision Date
    October 31, 1980
    Product Code
    CIZ
    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
    CIZ Radioimmunoassay, Androstenedione

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    Other Clearances by Diagnostics Biochem Canada, Inc.

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    K864966 ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE
    K832297 HYDROXYPROGESTERONE-17
    K781310 HUMAN CHORIONIC GONADO.-BETA RIA KIT