FDA 510(k) Applications Submitted by Co-Innovation Biotech Co.,Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K140748 03/25/2014 ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD CO-INNOVATION BIOTECH CO.,LTD.
K241100 04/22/2024 Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard Co-Innovation Biotech Co.,Ltd.
K231904 06/28/2023 Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard Co-Innovation Biotech Co.,Ltd.
K213808 12/06/2021 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 Co-Innovation Biotech Co.,Ltd.


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