Medical Device Manufacturer · CN , Hangzhou

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

3 submissions · 3 cleared · Since 2015

3

Total

3

Cleared

0

Denied

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

2 devices

1-2 of 2

Cleared Feb 24, 2016

Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG...

Chemistry · 153d

Cleared Oct 05, 2015

AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split...

Chemistry · 75d