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

    OPTILITE C1 INACTIVATOR KIT

    K Number: K141100 · Decision Jul 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    12
    Applicant Total
    43
    Review Days
    80

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    Basic Information

    Device Name
    OPTILITE C1 INACTIVATOR KIT
    K Number
    K141100
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5250
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site Group , Ltd.
    Date Received
    April 29, 2014
    Decision Date
    July 18, 2014
    Product Code
    DBA
    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
    DBA Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control

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    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
    Search all 43 clearances from The Binding Site Group , Ltd. →