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

    PASCO MIC AND MIC/ID PANELS

    K Number: K032259 · Decision Aug 19, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    PASCO MIC AND MIC/ID PANELS
    K Number
    K032259
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bd Diagnostic Systems
    Date Received
    July 22, 2003
    Decision Date
    August 19, 2003
    Product Code
    JWY
    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
    JWY Manual Antimicrobial Susceptibility Test Systems

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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
    K031429 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML
    K030091 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML