Shenzhen Lifotronic Technology Co

Lifotronic Technology announced on October 8 that it has recently received notification from the U.S. Food and Drug Administration that its H100Plus hemoglobin testing system has obtained FDA 510(k) clearance. The product is intended for in vitro quantitative determination of glycated hemoglobin (HbA1c) in human whole blood, which can assist in the diagnosis of diabetes. The company stated that obtaining FDA clearance demonstrates that the product meets the relevant requirements of the U.S. Food and Drug Administration and is qualified to enter the U.S. market. In the first half of 2026, Lifotronic Technology achieved revenue of 604 million yuan and net profit attributable to the parent company of 79.27 million yuan.