Medical Device Manufacturer · CN , Hangzhou

Assure Tech. (Hangzhou) Co, Ltd. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2016

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

FDA 510(k) Regulatory Record - Assure Tech. (Hangzhou) Co, Ltd. Toxicology ✕

6 devices

1-6 of 6

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