Shenzhen Lifotronic Technology's H100Plus Hemoglobin Testing System Receives FDA 510(k) Clearance
Stock News
2 hours ago
Shenzhen Lifotronic Technology Co.,Ltd. (688389.SH) has announced that it recently received notification from the U.S. Food and Drug Administration (FDA) that its H100Plus hemoglobin testing system has obtained FDA 510(k) clearance.
The product is used for the in vitro quantitative detection of glycated hemoglobin (HbA1c) in human whole blood and can assist in the diagnosis of diabetes.
The FDA 510(k) clearance indicates that the company's H100Plus hemoglobin testing system meets the relevant requirements of the FDA and is qualified for entry into the U.S. market, which is conducive to further enhancing the comprehensive competitiveness of the company's products in expanding into overseas markets.
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