BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT

    K Number: K070900 · Decision Nov 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    115
    Review Days
    242

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    Basic Information

    Device Name
    FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
    K Number
    K070900
    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, Ltd.
    Date Received
    April 2, 2007
    Decision Date
    November 30, 2007
    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

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    Other Clearances by The Binding Site, Ltd.

    K Number Device Name
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    K083289 HUMAN BETA-2 MICROGLOBULIN KIT
    K082129 HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
    K081827 HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
    K081674 BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
    K080384 HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
    K072889 HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
    K062372 FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
    K062183 FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
    Search all 115 clearances from The Binding Site, Ltd. →