Shenzhen Lifotronic Technology Co., Ltd. (688389.SH): H100Plus Hemoglobin Testing System Receives U.S. FDA 510(k) Clearance
Lifotronic Technology (688389.SH) announced that recently, the company received notification from the U.S. Food and Drug Administration ("FDA") that the company's H100Plus Hemoglobin Testing System has received U.S. FDA 510(k) clearance. This 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 product obtaining U.S. FDA 510(k) clearance indicates that the company's H100Plus Hemoglobin Testing System complies with the relevant FDA requirements and has the qualification to enter the U.S. market, which is conducive to further enhancing the comprehensive competitiveness of the company's products in expanding into overseas markets.
Shenzhen Lifotronic Technology Co., Ltd. (688389.SH) announced that it recently received notification from the U.S. Food and Drug Administration ("FDA") that the company's H100Plus Hemoglobin Testing System has received U.S. FDA 510(k) clearance. This 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 receipt of U.S. FDA 510(k) clearance for this product indicates that the company's H100Plus Hemoglobin Testing System complies with the relevant FDA requirements and has obtained market access qualification in the United States, which is conducive to further enhancing the company's comprehensive competitiveness in expanding its products into overseas markets.
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