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

    P2psa

    PMA: P090026 · Supplement: S017 · Decision Feb 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    P2psa
    Trade Name
    ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS
    PMA Number
    P090026
    Supplement Number
    S017
    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
    February 21, 2017
    Date Received
    January 23, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Manufacturing process change to the Working Strength Particle Batch Size process, which is used in the paramagnetic particle (PMP) for use in the Access Hybritech p2PSA Reagent.

    Classifications

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

    Product Code Device Name
    OYA P2psa