BEUDAMED
    FDA PMA FDA Class 1 30-Day Notice Accepted 🇺🇸 United States

    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

    PMA: P910007 · Supplement: S012 · Decision Sep 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180

    Basic Information

    Device Name
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
    Trade Name
    ABBOTT ARCHITECT TOTAL PSA
    PMA Number
    P910007
    Supplement Number
    S012
    Device Class
    FDA Class 1
    Product Code
    JJE
    Generic Name
    Analyzer, chemistry (photometric, discrete), for clinical use
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Advisory Committee
    Immunology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 10, 2004
    Date Received
    August 30, 2004
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO THE METHOD FOR ADDITION OF MAK-33 TO THE ANTI-PSA COATED MICROPARTICLES COMPONENT OF THE REAGENT PACK FOR THE ABBOTT ARCHITECT TOTAL PSA.

    Classifications

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

    Product Code Device Name
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use