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510(k) Data Aggregation

    K Number
    K960427
    Device Name
    ABBOTT CELL-DYN 3500R SYSTEM
    Manufacturer
    SEQUOIA TURNER CORP.
    Date Cleared
    1996-05-02

    (94 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEQUOIA TURNER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cell-Dyn® 3500R System is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories.
    Device Description
    The Cell-Dyn 3500R System is a table-top analyzer consisting of the main analyzer, data station, and printer. The instrument has two sampling modes: Open Sample Aspiration Mode and Closed Sample Aspiration Mode. The Cell-Dyn 3500R System is available with a manual Closed Sampler (3500R, CS) or an automated Sample Loader (3500R, SL). The instrument has the capability of processing a whole-blood specimen to provide a CBC, including a 5-part WBC differential for a total of 22 parameters. The 22 reportable parameters are as follows: White blood cells (WBC), red blood cells (RBC), platelets (PLT), percent of neutrophils (%N), number of neutrophils (NEU), percent of lymphocytes (%L), number of lymphocytes (LYM), percent of monocytes (%M), number of monocytes (MONO), percent of eosinophils (%E), number of eosinophils (EOS), percent of basophils (%B), number of basophils (BASO), hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW) mean platelet volume (MPV). In addition, the Reticulocyte software allows the instrument to process stained, diluted specimens in the Open Mode to provide a Reticulocyte percent (RETIC %), and number of Reticulocytes Absolute Number (Retic Abs). A Retic Scatter Index is provided for Laboratory Use Only and is not reportable.
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