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Co-Innovation Biotech Co., Ltd.

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories4
Latest Approval2024-05-22
TypeNumberDevice NameCodeDate
510(k) K241100 Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard NGL 2024-05-22 View
510(k) K231904 Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard DJG 2024-03-08 View
510(k) K232732 Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 LDJ 2024-01-17 View
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 LCX 2022-04-05 View
510(k) K153050 Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard DJG 2016-04-26 View