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

    BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML

    K Number: K030091 · Decision Feb 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    288
    Applicant Total
    5
    Review Days
    49

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    Basic Information

    Device Name
    BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML
    K Number
    K030091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1645
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bd Diagnostic Systems
    Date Received
    January 10, 2003
    Decision Date
    February 28, 2003
    Product Code
    LON
    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
    LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

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    Other Clearances by Bd Diagnostic Systems

    K Number Device Name
    K032518 PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)
    K032153 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML
    K032259 PASCO MIC AND MIC/ID PANELS
    K031429 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML