LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K955795
    Device Name
    MULTI-CENTRIFUGE
    Manufacturer
    NOVONX, INC.
    Date Cleared
    1996-03-29

    (98 days)

    Product Code
    GKG
    Regulation Number
    864.6400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVONX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The Multi-Centrifuge is a device that includes a centrifuge and a manual hematocrit reader. The hematocrit reader utilizes various distances to calculate a ratio (Hct) of Red Blood Cells to blood sample volume. These distances are at key separation (interface) points marked by the user. The device uses a flat disk rotor, resulting in interface points that are perpendicular to the hematocrit tube length. The marked interface points are Sealant/Red Blood Cells (Point A), Red Blood Cells/Plasma (Point B), and Plasma/Air (Point C). A microprocessor uses the equation (A + B) / (A + C) x 100 to calculate the ratio. The device has a larger LCD display compared to the predicate device.
    Ask a Question

    Page 1 of 1