Zhitong Finance App News, Pumen Technology (688389.SH) issued an announcement. Recently, the company received a notice from the US Food and Drug Administration (“FDA”), and the company's H100plus hemoglobin testing system was approved by the US FDA 510 (k). This product is used to quantitatively detect the content of glycated hemoglobin (HbA1c) in human whole blood in vitro, which can assist in the diagnosis of diabetes. This product has obtained US FDA 510 (k) approval, indicating that the company's H100plus hemoglobin testing system meets the relevant FDA requirements and is eligible for the US market, which is conducive to further enhancing the overall competitiveness of the company's products in developing overseas markets.
Zhitongcaijing · 1d ago
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Zhitong Finance App News, Pumen Technology (688389.SH) issued an announcement. Recently, the company received a notice from the US Food and Drug Administration (“FDA”), and the company's H100plus hemoglobin testing system was approved by the US FDA 510 (k). This product is used to quantitatively detect the content of glycated hemoglobin (HbA1c) in human whole blood in vitro, which can assist in the diagnosis of diabetes. This product has obtained US FDA 510 (k) approval, indicating that the company's H100plus hemoglobin testing system meets the relevant FDA requirements and is eligible for the US market, which is conducive to further enhancing the overall competitiveness of the company's products in overseas markets.
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