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Medical Devices / Submissions and Approvals

FDA Clears Beckman Coulter’s Hematology Analyzer

March 22, 2019

The FDA granted 510(k) clearance for Beckman Coulter’s DxH 520 hematology analyzer, a device for counting leucocytes, platelets and red cells in blood samples.

The device requires only 17 microliters of blood for an assessment, making it ideal for neonate, pediatric and critical-care patients that are not able to give larger samples.

The tabletop system uses a closed tube analyzer to reduce manual steps and improve safety for lab technicians by removing the need for sample exposure, and uses a touch screen that needs only three touches to access any menu.

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