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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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