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

    SERODIA ATG

    K Number: K953066 · Decision Aug 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    45

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    Basic Information

    Device Name
    SERODIA ATG
    K Number
    K953066
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fujirebio America, Inc.
    Date Received
    June 30, 1995
    Decision Date
    August 14, 1995
    Product Code
    DDC
    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
    DDC Thyroglobulin, Antigen, Antiserum, Control

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