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

    RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA

    K Number: K910304 · Decision Jul 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    39
    Review Days
    183

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    Basic Information

    Device Name
    RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA
    K Number
    K910304
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Vitek Systems, Inc.
    Date Received
    January 24, 1991
    Decision Date
    July 26, 1991
    Product Code
    LQL
    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
    LQL Gram Positive Identification Panel

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