Medical Device Manufacturer · US , Wilmington , DE

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

5 submissions · 5 cleared · Since 2024

5

Total

5

Cleared

0

Denied

FDA 510(k) cleared devices by Assure Tech., LLC Chemistry ✕

2 devices

1-2 of 2

Cleared Feb 13, 2025

FaStep Pregnancy Rapid Test Cassette

Chemistry · 28d

Cleared Jan 15, 2025

FaStep Early Pregnancy Rapid Test Strip

Chemistry · 57d