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Assure Tech., LLC

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories3
Latest Approval2025-08-15
TypeNumberDevice NameCodeDate
510(k) K252259 AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup NFT 2025-08-15 View
510(k) K250117 FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette LCX 2025-02-13 View
510(k) K243996 AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup NFT 2025-02-07 View
510(k) K243573 FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream LCX 2025-01-15 View
510(k) K240351 FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) NGL 2024-03-06 View
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