BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

    PMA: P870049 · Supplement: S025 · Decision May 3, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
    Trade Name
    MICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS
    PMA Number
    P870049
    Supplement Number
    S025
    Device Class
    FDA Class 2
    Product Code
    LON
    Generic Name
    SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
    Regulation Number
    866.1645
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 3, 1996
    Date Received
    September 28, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR EXPANDED GENTAMICIN DILUTIONS AT CONCENTRATIONS OF 0.12-4, 6, AND 8UG/ML, THE REMOVAL OF THE LIMITATION FOR THE TESTING OF SALMONELLA/SHIGELLA WITH GENTAMICIN, AND ADDITIONAL LIMITATIONS FOR THE TESTING OF ACINETOBACTER BAUMANII AND STENOTROPHOMONAS MALTOPHILIA WITH GENTAMICIN

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation