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

    HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS

    K Number: K082823 · Decision Mar 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    60
    Applicant Total
    18
    Review Days
    522

    Basic Information

    Device Name
    HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS
    K Number
    K082823
    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
    September 25, 2008
    Decision Date
    March 1, 2010
    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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