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

    N Latex FLC kappa, N Latex FLC lambda

    K Number: K190879 · Decision May 3, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    19
    Review Days
    29

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    Basic Information

    Device Name
    N Latex FLC kappa, N Latex FLC lambda
    K Number
    K190879
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics Products GmbH
    Date Received
    April 4, 2019
    Decision Date
    May 3, 2019
    Product Code
    DFH
    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
    DFH Kappa, Antigen, Antiserum, Control

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