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

    RUBELISA TEST KIT

    K Number: K792133 · Decision Jan 11, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    8
    Review Days
    81

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    Basic Information

    Device Name
    RUBELISA TEST KIT
    K Number
    K792133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microbiological Assoc.
    Date Received
    October 22, 1979
    Decision Date
    January 11, 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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