Co-Innovation Biotech Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Co-Innovation Biotech Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Rapid Urine Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard, Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
10
Total
10
Cleared
0
Denied
Co-Innovation Biotech Co., Ltd. has 10 FDA 510(k) cleared toxicology devices. Based in Guangzhou, Guangdong, CN.
Latest FDA clearance: May 2024. Active since 2013.
Browse the complete list of FDA 510(k) cleared toxicology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Co-Innovation Biotech Co., Ltd.
10 devices
Cleared
May 22, 2024
Rapid Urine Fentanyl (FYL) Test Strip
Toxicology
30d
Cleared
Mar 08, 2024
Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
Toxicology
254d
Cleared
Jan 17, 2024
Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20,...
Toxicology
132d
Cleared
Apr 05, 2022
Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip,...
Chemistry
120d
Cleared
Apr 26, 2016
Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
Toxicology
189d
Cleared
Dec 11, 2014
Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
Toxicology
73d
Cleared
Aug 20, 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD
Toxicology
148d
Cleared
Jun 16, 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
Toxicology
139d
Cleared
Jan 15, 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP
Toxicology
271d
Cleared
Nov 12, 2013
ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
Chemistry
130d