BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇿 Czechia

    ACTIVE® Free Testosterone RIA

    K Number: K191350 · Decision Dec 20, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    88
    Applicant Total
    1
    Review Days
    214

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    Basic Information

    Device Name
    ACTIVE® Free Testosterone RIA
    K Number
    K191350
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    862.1680
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Immunotech S.R.O.
    Date Received
    May 20, 2019
    Decision Date
    December 20, 2019
    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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