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

    N ANTISERUM TO HUMAN TRANSFERRIN

    K Number: K972840 · Decision Oct 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    47
    Applicant Total
    145
    Review Days
    77

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    Basic Information

    Device Name
    N ANTISERUM TO HUMAN TRANSFERRIN
    K Number
    K972840
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5880
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Behring Diagnostics, Inc.
    Date Received
    August 1, 1997
    Decision Date
    October 17, 1997
    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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