510(k) K240351

FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) by Assure Tech., LLC — Product Code NGL

K240351 is an FDA 510(k) premarket notification submitted by Assure Tech., LLC for the device "FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)". The FDA issued a decision of Substantially Equivalent on March 6, 2024. The device falls under product code NGL (Test, Opiates, Over The Counter), a Class II device regulated under 21 CFR 862.3650. Assure Tech., LLC has at least 6 other 510(k) clearances on record.