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

    ANTI-HUMAN C1 INHIBITOR SERUM (GOAT)

    K Number: K781017 · Decision Aug 14, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    12
    Applicant Total
    48
    Review Days
    59

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    Basic Information

    Device Name
    ANTI-HUMAN C1 INHIBITOR SERUM (GOAT)
    K Number
    K781017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5250
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Icl Scientific
    Date Received
    June 16, 1978
    Decision Date
    August 14, 1978
    Product Code
    DBA
    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
    DBA Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control

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