BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    P2psa

    PMA: P090026 · Supplement: S023 · Decision Jan 9, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    P2psa
    Trade Name
    Access Hybritech p2PSA Reagent Pack
    PMA Number
    P090026
    Supplement Number
    S023
    Device Class
    FDA Class 3
    Product Code
    OYA
    Generic Name
    P2psa
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 9, 2019
    Date Received
    December 17, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change to the process for the Access p2PSA calibrator verification testing.

    Classifications

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

    Product Code Device Name
    OYA P2psa