BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    P2psa

    PMA: P090026 · Supplement: S032 · Decision Jun 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    P2psa
    Trade Name
    Access Hybritech p2PSA
    PMA Number
    P090026
    Supplement Number
    S032
    Device Class
    FDA Class 3
    Product Code
    OYA
    Generic Name
    P2psa
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 16, 2025
    Date Received
    December 18, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    migration of the Access Hybritech p2PSA Reagents to the Dxl 9000 Access Immunoassay Analyzer

    Classifications

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

    Product Code Device Name
    OYA P2psa