BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit

    K Number: K250549 · Decision May 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    43
    Review Days
    87

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    Basic Information

    Device Name
    Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
    K Number
    K250549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Binding Site Group , Ltd.
    Date Received
    February 25, 2025
    Decision Date
    May 23, 2025
    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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    Other Clearances by The Binding Site Group , Ltd.

    K Number Device Name
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    K192116 Human IgA liquid reagent kit for Use on SPAPlus
    K191985 Optilite IgA Kit
    K191635 Optilite IgM Kit
    K191465 Human IgM Kit for use on SPAPlus
    K190686 Optilite IgM CSF Kit
    K183151 Optilite IgA CSF Kit
    K180099 Optilite High Sensitivity C-Reactive Protein Kit
    K173732 Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
    K172868 Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
    Search all 43 clearances from The Binding Site Group , Ltd. →