
Assure Tech., LLC
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FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) is an FDA 510(k)-cleared medical device (K240351) manufactured by Assure Tech., LLC. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 5, 2024. Regulation: 8.