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 Toxicology ✕

3 devices

1-3 of 3

Cleared Aug 15, 2025

AssureTech Quick Cup Tests

Toxicology · 25d

Cleared Feb 07, 2025

AssureTech Panel Dip Tests

Toxicology · 43d

Cleared Mar 06, 2024

FaStep Fentanyl Rapid Test Device (Urine)

Toxicology · 30d