BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Susceptibility Test Cards, Antimicrobial

    PMA: N50510 · Supplement: S146 · Decision Oct 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Susceptibility Test Cards, Antimicrobial
    Trade Name
    VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL
    PMA Number
    N50510
    Supplement Number
    S146
    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
    October 17, 2001
    Date Received
    September 17, 2001
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A LABELING CHANGE TO ADD AN INSTRUCTION TO THE VITEK 2 USER'S MANUAL WHICH DESCRIBES ADDITIONAL VISUAL OBSERVATION STEPS TO THE PROCEDURE FOR THE INSTALLATION OF THE VITEK 2 ACCESSORY KIT AND SALINE BAG.

    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