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

    SLIDEX MENINGITE-KIT 5

    K Number: K910210 · Decision Aug 12, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    15
    Applicant Total
    39
    Review Days
    209

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    Basic Information

    Device Name
    SLIDEX MENINGITE-KIT 5
    K Number
    K910210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Vitek Systems, Inc.
    Date Received
    January 15, 1991
    Decision Date
    August 12, 1991
    Product Code
    GTJ
    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
    GTJ Antisera, All Groups, N. Meningitidis

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