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

    HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS

    K Number: K140664 · Decision Apr 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    43
    Review Days
    29

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    Basic Information

    Device Name
    HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS
    K Number
    K140664
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5620
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site Group , Ltd.
    Date Received
    March 18, 2014
    Decision Date
    April 16, 2014
    Product Code
    DEB
    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
    DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control

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