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

    CAPI 3 Immunotyping, Capillarys 3 Tera

    K Number: K192095 · Decision Nov 1, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    28
    Applicant Total
    32
    Review Days
    88

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    Basic Information

    Device Name
    CAPI 3 Immunotyping, Capillarys 3 Tera
    K Number
    K192095
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sebia
    Date Received
    August 5, 2019
    Decision Date
    November 1, 2019
    Product Code
    CFF
    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
    CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)

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