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Assure Tech., LLC

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories4
Latest FDA decision2026-07-17
TypeNumberDevice NameCodeDateActions
510(k) K261984 AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupNFT2026-07-17 View
510(k) K260754 Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestQYT2026-06-05 View
510(k) K252259 AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT2025-08-15 View
510(k) K250117 FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX2025-02-13 View
510(k) K243996 AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test CupNFT2025-02-07 View
510(k) K243573 FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamLCX2025-01-15 View
510(k) K240351 FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)NGL2024-03-06 View
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