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

    BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN

    K Number: K033454 · Decision Mar 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    91
    Applicant Total
    6
    Review Days
    144

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    Basic Information

    Device Name
    BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
    K Number
    K033454
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Brahms Diagnostica, LLC
    Date Received
    October 30, 2003
    Decision Date
    March 22, 2004
    Product Code
    JZO
    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
    JZO System, Test, Thyroid Autoantibody

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    Other Clearances by Brahms Diagnostica, LLC

    K Number Device Name
    K021057 BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS
    K000286 BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
    K000287 BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO
    K992791 BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
    K992790 BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG