BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)

    K Number: K014120 · Decision Feb 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    88
    Applicant Total
    6
    Review Days
    53

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    Basic Information

    Device Name
    TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)
    K Number
    K014120
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1680
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostics Biochem Canada, Inc.
    Date Received
    December 17, 2001
    Decision Date
    February 8, 2002
    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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    Other Clearances by Diagnostics Biochem Canada, Inc.

    K Number Device Name
    K030730 FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT
    K864966 ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE
    K832297 HYDROXYPROGESTERONE-17
    K801729 ANDROSTENEDIONE RADIOIMMUNOASSAY KIT
    K781310 HUMAN CHORIONIC GONADO.-BETA RIA KIT