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 Chemistry ✕
2 devices
1-2 of 2
Cleared Feb 13, 2025
FaStep Pregnancy Rapid Test Cassette
K250117 · LCX
Chemistry · 28d
Cleared Jan 15, 2025
FaStep Early Pregnancy Rapid Test Strip
K243573 · LCX
Chemistry · 57d
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