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) Regulatory Record - Assure Tech., LLC Toxicology ✕
3 devices
1-3 of 3
Cleared Aug 15, 2025
AssureTech Quick Cup Tests
K252259 · NFT
Toxicology · 25d
Cleared Feb 07, 2025
AssureTech Panel Dip Tests
K243996 · NFT
Toxicology · 43d
Cleared Mar 06, 2024
FaStep Fentanyl Rapid Test Device (Urine)
K240351 · NGL
Toxicology · 30d
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