Assure Tech., LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Known Names

assure tech, assure tech. co

Recent 510(k) Clearances

K-NumberDeviceDate
K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupAugust 15, 2025
K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteFebruary 13, 2025
K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssuFebruary 7, 2025
K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early PrJanuary 15, 2025
K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)March 6, 2024