BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    VARELISA SM ANTIBODIES, MODEL 18296

    K Number: K042629 · Decision Dec 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    27
    Applicant Total
    8
    Review Days
    72

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    Basic Information

    Device Name
    VARELISA SM ANTIBODIES, MODEL 18296
    K Number
    K042629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sweden Diagnostics (Germany) GmbH
    Date Received
    September 27, 2004
    Decision Date
    December 8, 2004
    Product Code
    LKP
    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
    LKP Anti-Sm Antibody, Antigen And Control

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