Assure Tech. (Hangzhou) Co, Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Assure Tech. (Hangzhou) Co, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: FaStep™ Pregnancy Rapid Test Strip, AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests, AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
7
Total
7
Cleared
0
Denied
Assure Tech. (Hangzhou) Co, Ltd. has 7 FDA 510(k) cleared medical devices. Based in Hangzhou, CN.
Latest FDA clearance: Feb 2024. Active since 2016. Primary specialty: Toxicology.
Browse the FDA 510(k) cleared devices submitted by Assure Tech. (Hangzhou) Co, Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Lsi International as regulatory consultant.
FDA 510(k) Regulatory Record - Assure Tech. (Hangzhou) Co, Ltd.
7 devices
Cleared
Feb 05, 2024
FaStep™ Pregnancy Rapid Test Strip
Chemistry
130d
Cleared
Aug 12, 2021
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
Toxicology
422d
Cleared
Aug 20, 2018
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
Toxicology
48d
Cleared
Apr 05, 2018
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
Toxicology
56d
Cleared
May 02, 2017
AssureTech Panel Dip Test, AssureTech Quick Cup Test
Toxicology
117d
Cleared
Jul 06, 2016
AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key...
Toxicology
84d
Cleared
Mar 31, 2016
AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split...
Toxicology
121d