# Assure Tech., LLC

- Location (FDA's records): Wilmington, DE
- FDA decisions: 10 (2015–2026): 10 510(k) clearances
- Names in FDA's records: Assure Tech., LLC (7); Assure Tech. Co., Ltd. (3)
- Product codes: NFT (3), LCX (2), DIS (1), DJR (1), JHI (1), NGL (1), QYT (1)
- 510(k) review time since 2016: median 35 days, against 40 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- First Check Diagnostics, LLC: 1 (https://510kreport.com/company/first-check-diagnostics)
- Chemtron Biotech, Inc.: 1 (https://510kreport.com/company/chemtron-biotech)
- Quidel Corp.: 1 (https://510kreport.com/company/quidel)
- Guangzhou Wondfo Biotech Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-wondfo-biotech)
- Hangzhou AllTest Biotech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-alltest-biotech)
- Assure Tech. (Hangzhou) Co, Ltd.: 1 (https://510kreport.com/company/assure-tech-hangzhou)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)

## Its most-cited devices
- K252259: AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup (2025), cited by 1
- K152768: Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip (2016), cited by 1
- K243996: AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup (2025), cited by 1

## Recent decisions
- K261984: AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup (Jul 17, 2026)
- K260754: Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test (Jun 5, 2026)
- K252259: AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup (Aug 15, 2025)
- K250117: FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (Feb 13, 2025)
- K243996: AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup (Feb 7, 2025)
- K243573: FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream (Jan 15, 2025)
- K240351: FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) (Mar 6, 2024)
- K152768: Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip (Feb 24, 2016)

Source page: https://510kreport.com/company/assure-tech