BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Susceptibility Test Cards, Antimicrobial

    PMA: N50510 · Supplement: S066 · Decision Nov 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Susceptibility Test Cards, Antimicrobial
    Trade Name
    VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD
    PMA Number
    N50510
    Supplement Number
    S066
    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
    November 3, 1994
    Date Received
    October 4, 1994
    Expedited Review
    N

    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