BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS

    K Number: K021057 · Decision Sep 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    169

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    Basic Information

    Device Name
    BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS
    K Number
    K021057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brahms Diagnostica, LLC
    Date Received
    April 1, 2002
    Decision Date
    September 17, 2002
    Product Code
    MSW
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MSW System, Test, Thyroglobulin

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    Other Clearances by Brahms Diagnostica, LLC

    K Number Device Name
    K033454 BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
    K000286 BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
    K000287 BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO
    K992791 BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
    K992790 BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG