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

    BINDING SITE IGG SUBLCASS OLYMPUS KITS

    K Number: K042152 · Decision Nov 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    60
    Applicant Total
    10
    Review Days
    105

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    Basic Information

    Device Name
    BINDING SITE IGG SUBLCASS OLYMPUS KITS
    K Number
    K042152
    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 9, 2004
    Decision Date
    November 22, 2004
    Product Code
    CFN
    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
    CFN Method, Nephelometric, Immunoglobulins (G, A, M)

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    K132555 HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
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    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
    K041891 MININEPH HUMAN RHEUMATOID FACTOR KIT
    K040466 BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS