BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    P2psa

    PMA: P090026 · Supplement: S012 · Decision Dec 23, 2014
    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
    S012
    Device Class
    FDA Class 3
    Product Code
    OYA
    Generic Name
    P2psa
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 23, 2014
    Date Received
    August 25, 2014
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE CURRENT REAGENT REAL-TIME STABILITY TEST METHOD FOR ACCESS REAGENT PACKS, CALIBRATORS AND SAMPLES DILUENTS TO ENHANCE THE SAFETY AND RELIABILITY OF THE DEVICES PER 21 CFR 814.39(D)(2).

    Classifications

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

    Product Code Device Name
    OYA P2psa