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

    Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit

    K Number: K152389 · Decision Dec 18, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    43
    Review Days
    116

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
    K Number
    K152389
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site Group , Ltd.
    Date Received
    August 24, 2015
    Decision Date
    December 18, 2015
    Product Code
    PDE
    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
    PDE Immunoglobulin M Kappa Heavy And Light Chain Combined

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PDE), ordered by most recent decision date.

    HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    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
    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. →