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

    GOAT ANTI-HUMAN COMPLEMENT C4

    K Number: K802196 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    33
    Applicant Total
    6
    Review Days
    51

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    Basic Information

    Device Name
    GOAT ANTI-HUMAN COMPLEMENT C4
    K Number
    K802196
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Protos Laboratories
    Date Received
    September 10, 1980
    Decision Date
    October 31, 1980
    Product Code
    DBI
    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
    DBI Complement C4, Antigen, Antiserum, Control

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