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

    Optilite IgM CSF Kit

    K Number: K190686 · Decision May 28, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    60
    Applicant Total
    7
    Review Days
    71

    Basic Information

    Device Name
    Optilite IgM CSF Kit
    K Number
    K190686
    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
    March 18, 2019
    Decision Date
    May 28, 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
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    K172868 Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
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