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

    ANTIBODY TO RUBELLA VIRUS

    K Number: K792635 · Decision Mar 19, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    41
    Review Days
    91

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    Basic Information

    Device Name
    ANTIBODY TO RUBELLA VIRUS
    K Number
    K792635
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Electro-Nucleonics Laboratories, Inc.
    Date Received
    December 19, 1979
    Decision Date
    March 19, 1980
    Product Code
    GOK
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GOK Antisera, Hai (Including Hai Control), Rubella

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