BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Discs, Elution

    PMA: N50485 · Supplement: S015 · Decision Aug 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Discs, Elution
    Trade Name
    AMIKACIN ELUTION DISK FOR AUTOBAC
    PMA Number
    N50485
    Supplement Number
    S015
    Device Class
    FDA Class 2
    Product Code
    LTX
    Generic Name
    DISCS, ELUTION
    Regulation Number
    866.1620
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 10, 1987
    Date Received
    April 22, 1987
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LTX Discs, Elution