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

    HUMAN IGD KIT FOR USE ON SPAPLUS

    K Number: K092450 · Decision Dec 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    7
    Applicant Total
    10
    Review Days
    140

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    Basic Information

    Device Name
    HUMAN IGD KIT FOR USE ON SPAPLUS
    K Number
    K092450
    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 10, 2009
    Decision Date
    December 28, 2009
    Product Code
    CZJ
    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
    CZJ Igd, Antigen, Antiserum, Control

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