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

    Optilite IgA CSF Kit

    K Number: K183151 · Decision Jan 23, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    60
    Applicant Total
    43
    Review Days
    70

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    Basic Information

    Device Name
    Optilite IgA CSF Kit
    K Number
    K183151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Binding Site Group , Ltd.
    Date Received
    November 14, 2018
    Decision Date
    January 23, 2019
    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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    Other Clearances by The Binding Site Group , Ltd.

    K Number Device Name
    K250159 Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
    K250549 Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
    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
    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. →