510(k) K202188

Safety Blood Collection Sets for Single Use by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — Product Code JKA

K202188 is an FDA 510(k) premarket notification submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. for the device "Safety Blood Collection Sets for Single Use". The FDA issued a decision of Substantially Equivalent on February 19, 2021. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. has at least 10 other 510(k) clearances on record.