Chrysalis Intelligence · Sponsors · Assure Tech., LLC

Assure Tech., LLC

Wilmington, DE, US · 7 510(k) clearances

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Total clearances
7
2024-03-06 → 2026-07-17
Last 12 months
2
Product codes
4
Most recent
2026-07-17
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NFT Test, Amphetamine, Over The Counter Class II Clinical Toxicology 3 2026-07-17
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Class II Clinical Chemistry 2 2025-02-13
QYT Over-The-Counter Covid-19 Antigen Test Class II Microbiology 1 2026-06-05
NGL Test, Opiates, Over The Counter Class II Clinical Toxicology 1 2024-03-06
Filings

All 510(k) clearances (7)

Date K-number Device Code Class Specialty
2026-07-17 K261984 AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup NFT Class II Clinical Toxicology
2026-06-05 K260754 Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test QYT Class II Microbiology
2025-08-15 K252259 AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup NFT Class II Clinical Toxicology
2025-02-13 K250117 FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette LCX Class II Clinical Chemistry
2025-02-07 K243996 AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup NFT Class II Clinical Toxicology
2025-01-15 K243573 FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream LCX Class II Clinical Chemistry
2024-03-06 K240351 FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) NGL Class II Clinical Toxicology
Data source: openFDA · Generated 2026-08-16 09:28 · Last ingest 2026-08-16T13:28:42.353878 · Pipeline: Chrysalis Intelligence