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

    ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805

    K Number: K060431 · Decision Jun 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    118

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    Basic Information

    Device Name
    ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805
    K Number
    K060431
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mbl International Corporation
    Date Received
    February 21, 2006
    Decision Date
    June 19, 2006
    Product Code
    NYO
    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
    NYO Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

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    Other Clearances by Mbl International Corporation

    K Number Device Name
    K071961 MESACUP MODELS BP180 AND BP230 ELISA KITS