510(k) K213808

Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream by Co-Innovation Biotech Co., Ltd. — Product Code LCX

K213808 is an FDA 510(k) premarket notification submitted by Co-Innovation Biotech Co., Ltd. for the device "Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream". The FDA issued a decision of Substantially Equivalent on April 5, 2022. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Co-Innovation Biotech Co., Ltd. has at least 9 other 510(k) clearances on record.