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

    SPAPLUS ANALYZER

    K Number: K100455 · Decision Sep 3, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    33
    Applicant Total
    10
    Review Days
    198

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    Basic Information

    Device Name
    SPAPLUS ANALYZER
    K Number
    K100455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Binding Site
    Date Received
    February 17, 2010
    Decision Date
    September 3, 2010
    Product Code
    DBI
    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
    DBI Complement C4, Antigen, Antiserum, Control

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