BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION

    K Number: K910666 · Decision Apr 3, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    17
    Applicant Total
    39
    Review Days
    51

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    Basic Information

    Device Name
    VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION
    K Number
    K910666
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Vitek Systems, Inc.
    Date Received
    February 11, 1991
    Decision Date
    April 3, 1991
    Product Code
    JSP
    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
    JSP Kit, Anaerobic Identification

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