October 5, 2026- HORIBA announced the Yumizen H550 Hematology Analyzer has received U.S. Food and Drug Administration (FDA) 510(k) clearance for in vitro diagnostic use in clinical laboratories.The Yumizen H550 is a high-performance hematology analyzer designed to classify and enumerate Complete Blood Count (CBC) parameters and provide a comprehensive 6-part White Blood Cell differential, including the Immature Granulocyte (IMG) count. The analyzer delivers accurate and reliable hematology results to support clinical decision-making for both adult and pediatric patient populations.The FDA-cleared Yumizen H550 complements the existing HORIBA hematology and clinical chemistry portfolio, further expanding the company’s ability to provide laboratories with advanced diagnostic solutions that meet a broad range of clinical testing needs.
The Yumizen H550 is intended for the analysis of venous and capillary whole blood samples and is designed to assist laboratories in the screening of physiological and pathological samples through the detection of quantitative and qualitative hematological abnormalities. The analyzer provides comprehensive hematology information that can aid healthcare professionals in evaluating patient populations encountered in routine clinical laboratory settings.
Key features of the Yumizen H550 include:
- Complete Blood Count (CBC) analysis
- 6-part White Blood Cell differential, including Immature Granulocyte (IMG) enumeration
- Testing capabilities for adult and pediatric patient populations
- Compatibility with venous and capillary whole blood samples
- In vitro diagnostic use in clinical laboratory environments
The FDA 510(k) clearance of the Yumizen H550 expands the HORIBA Yumizen Hematology Portfolio, adding a solution for low-to-mid volume testing alongside the Yumizen H2500 for high-volume laboratories. Together, these analyzers support clinical laboratories across the United States with advanced hematology testing capabilities designed to enhance workflow efficiency and support high-quality patient care.
For more information about the Yumizen H550 Hematology Analyzer and the complete product portfolio from HORIBA, visit
https://www.horiba.com/usa/medical/products/hematology/