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

    HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT

    K Number: K132555 · Decision Dec 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    10
    Review Days
    128

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    Basic Information

    Device Name
    HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
    K Number
    K132555
    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
    Date Received
    August 14, 2013
    Decision Date
    December 20, 2013
    Product Code
    PCN
    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
    PCN Immunoglobulin G Kappa Heavy And Light Chain Combined

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    Other Clearances by The Binding Site

    K Number Device Name
    K140105 HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
    K103824 HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
    K100455 SPAPLUS ANALYZER
    K092450 HUMAN IGD KIT FOR USE ON SPAPLUS
    K072166 CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER
    K042579 BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
    K042152 BINDING SITE IGG SUBLCASS OLYMPUS KITS
    K041891 MININEPH HUMAN RHEUMATOID FACTOR KIT
    K040466 BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS