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

    Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit

    K Number: K150658 · Decision Aug 26, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    61
    Applicant Total
    18
    Review Days
    166

    Basic Information

    Device Name
    Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit
    K Number
    K150658
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    THE BINDING SITE GROUP LTD
    Date Received
    March 13, 2015
    Decision Date
    August 26, 2015
    Product Code
    DFH
    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
    DFH Kappa, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2

    FDA 510(k)
    FDA Class 2 ·Immunology

    Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2

    FDA 510(k)
    FDA Class 2 ·Immunology

    Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

    FDA 510(k)
    FDA Class 2 ·Immunology

    Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

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

    Other Clearances by THE BINDING SITE GROUP LTD

    K Number Device Name
    K161854 Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
    K153560 Optilite Low Level Albumin Kit
    K152389 Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
    K150526 Optilite IgG4 Kit
    K143118 Human Microalbumin kit for use on SPAPLUS
    K142735 The Optilite IgG3 kit
    K140686 HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
    K141100 OPTILITE C1 INACTIVATOR KIT
    K120749 HUMAN IGG CSF KIT
    K120750 HUMAN IGM CSF KIT
    Search all 18 clearances from THE BINDING SITE GROUP LTD →