BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Susceptibility Test Cards, Antimicrobial

    PMA: N50510 · Supplement: S086 · Decision Jun 24, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Susceptibility Test Cards, Antimicrobial
    Trade Name
    VITEK 2 SYSTEM
    PMA Number
    N50510
    Supplement Number
    S086
    Device Class
    FDA Class 2
    Product Code
    LTW
    Generic Name
    Susceptibility test cards, antimicrobial
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 24, 1999
    Date Received
    March 16, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for software revisions for major modifications to the design of the device in order to automate manual operations and enhance performance. The device as modified will be marketed under the trade name VITEK(R) 2 System and is intended as a laboratory aid in the determination of the in vitro susceptibility of bacteria when tested on a Gram Negative Susceptibility Test Card or a Gram Positive Susceptibility Test Card containing antimicrobial agents at selected concentrations.

    Classifications

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

    Product Code Device Name
    LTW Susceptibility Test Cards, Antimicrobial