FDA 510(k) Applications Submitted by Allen Chen

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


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