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. Chemistry ✕

1 devices

1-1 of 1

Cleared Feb 05, 2024

FaStep™ Pregnancy Rapid Test Strip

Chemistry · 130d