BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    TRANSFERRIN KIT FOR USE ON THE SPAPLUS

    K Number: K120236 · Decision Feb 13, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    47
    Applicant Total
    43
    Review Days
    384

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    Basic Information

    Device Name
    TRANSFERRIN KIT FOR USE ON THE SPAPLUS
    K Number
    K120236
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5880
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site Group , Ltd.
    Date Received
    January 26, 2012
    Decision Date
    February 13, 2013
    Product Code
    DDG
    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
    DDG Transferrin, Antigen, Antiserum, Control

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    K190686 Optilite IgM CSF Kit
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