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

    WELLCOGEN N. MENINGITIDIS A,C,Y W135

    K Number: K833063 · Decision Jan 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    15
    Applicant Total
    28
    Review Days
    123

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    Basic Information

    Device Name
    WELLCOGEN N. MENINGITIDIS A,C,Y W135
    K Number
    K833063
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Wellcome Diagnostics
    Date Received
    September 9, 1983
    Decision Date
    January 10, 1984
    Product Code
    GTJ
    Advisory Committee
    Microbiology
    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
    GTJ Antisera, All Groups, N. Meningitidis

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