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

    P2psa

    PMA: P090026 · Supplement: S019 · Decision Jul 7, 2017
    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
    S019
    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
    July 7, 2017
    Date Received
    June 9, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Manufacturing change to update a specification to allow for a limited amount of flash local to the gate location (where plastic material is injected into the reaction vessel) for the Access 2 Reaction Vessels, which are used during the processing of the assays.

    Classifications

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

    Product Code Device Name
    OYA P2psa