Oct. 5, 2026—Horiba’s Yumizen H550 hematology analyzer has received FDA 510(k) clearance for in vitro diagnostic use in clinical laboratories. The analyzer is designed to classify and enumerate complete blood count parameters and provide a comprehensive six-part white blood cell differential, including the immature granulocyte count. It accepts venous and capillary whole blood samples and supports clinical decision-making for adult and pediatric patient populations.
The Yumizen H550 complements the company’s existing clinical chemistry and hematology portfolio, adding a solution for low- to mid-volume testing alongside the Yumizen H2500 hematology analyzer for high-volume laboratories.