510(k) K250117

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette by Assure Tech., LLC — Product Code LCX

K250117 is an FDA 510(k) premarket notification submitted by Assure Tech., LLC for the device "FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette". The FDA issued a decision of Substantially Equivalent on February 13, 2025. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Assure Tech., LLC has at least 6 other 510(k) clearances on record.