Medical Device Manufacturer · CN , Hangzhou

Hangzhou AllTest Biotech Co., Ltd. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2019

13

Total

13

Cleared

0

Denied

FDA 510(k) cleared devices by Hangzhou AllTest Biotech Co., Ltd. Chemistry ✕

4 devices

1-4 of 4

Cleared Oct 30, 2025

AllTest Urinary Tract Infection Test

Chemistry · 73d

Cleared Jul 15, 2025

Shinetell PlusTM Digital Early Pregnancy Test

Chemistry · 102d

Cleared Aug 13, 2024

Shinetell Digital Pregnancy Test

Chemistry · 39d

Cleared Jan 31, 2022

Alltest Pregnancy Rapid Combo Test Cassette

Chemistry · 451d