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

    N Latex FLC kappa, N Latex FLC lambda

    K Number: K201496 · Decision Oct 29, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    61
    Applicant Total
    16
    Review Days
    511

    Basic Information

    Device Name
    N Latex FLC kappa, N Latex FLC lambda
    K Number
    K201496
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics Products GmbH
    Date Received
    June 5, 2020
    Decision Date
    October 29, 2021
    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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