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

    FREND Testosterone Test System

    K Number: K153577 · Decision Oct 14, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    88
    Applicant Total
    5
    Review Days
    304

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    Basic Information

    Device Name
    FREND Testosterone Test System
    K Number
    K153577
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1680
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanoentek USA, Inc.
    Date Received
    December 15, 2015
    Decision Date
    October 14, 2016
    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 Nanoentek USA, Inc.

    K Number Device Name
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