FDA 510(k) Applications Submitted by Assure Tech LLC

FDA 510(k) Number	Submission Date	Device Name	Applicant
K240351	02/05/2024	FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)	Assure Tech LLC
K243573	11/19/2024	FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream	Assure Tech LLC
K243996	12/26/2024	AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup	Assure Tech LLC
K250117	01/16/2025	FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette	Assure Tech LLC