BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

    PMA: P800029 · Decision Jan 30, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
    Trade Name
    API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM
    PMA Number
    P800029
    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 (Reclassification)
    Decision Code
    APRL
    Decision Date
    January 30, 1981
    Date Received
    June 2, 1980
    Expedited Review
    N

    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