BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

    K Number: K000930 · Decision May 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    322
    Applicant Total
    36
    Review Days
    61

    Basic Information

    Device Name
    GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
    K Number
    K000930
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1620
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    OXOID, LTD.
    Date Received
    March 22, 2000
    Decision Date
    May 22, 2000
    Product Code
    JTN
    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
    JTN Susceptibility Test Discs, Antimicrobial

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