BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    P2psa

    PMA: P090026 · Supplement: S009 · Decision Oct 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    P2psa
    Trade Name
    ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
    PMA Number
    P090026
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    OYA
    Generic Name
    P2psa
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 17, 2013
    Date Received
    September 26, 2013
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF PERIODIC REBOOTS IN THE MAINTENANCE SCHEDULE AND REVISING THE MAINTENANCE INSTRUCTIONS FOR THE UNICELDXI IMMUNOASSAY SYSTEMS.

    Classifications

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

    Product Code Device Name
    OYA P2psa