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

    ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2

    K Number: K040431 · Decision Mar 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    264
    Review Days
    20

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    Basic Information

    Device Name
    ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
    K Number
    K040431
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Corp.
    Date Received
    February 19, 2004
    Decision Date
    March 10, 2004
    Product Code
    DAO
    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
    DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control

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