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

    N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

    K Number: K233663 · Decision Dec 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    60
    Applicant Total
    19
    Review Days
    28

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    Basic Information

    Device Name
    N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
    K Number
    K233663
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics Products GmbH
    Date Received
    November 15, 2023
    Decision Date
    December 13, 2023
    Product Code
    CFN
    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
    CFN Method, Nephelometric, Immunoglobulins (G, A, M)

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