MedTech News

Tosoh Announces 510k Clearance for Highly Anticipated Next-Generation GR01 HbA1c Analyzer: A Fast, Accurate and Efficient Solution for A1c Testing

GROVE CITY, Ohio, Oct. 6, 2025 /PRNewswire/ — Tosoh Bioscience, Inc., a market leader in clinical diagnostics is proud to announce that it has received US FDA 510(k) clearance for its next-generation system for HbA1c testing – the Tosoh Automated Glycohemoglobin Analyzer HLC®723-GR01 (hereafter “GR01”). The GR01 is intended for monitoring the long-term blood glucose control of individuals with diabetes, as an aid in the diagnosis of diabetes and to help identify those who may be at risk of developing the disease.

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