AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup— 510(k) K252259

Name: FDA 510(k) clearance K252259
Creator: U.S. Food and Drug Administration
Published: 2025-08-15

Substantially Equivalent

Assure Tech., LLC

FDA 510(k) clearance K252259 for AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup, Substantially Equivalent on 2025-08-15. Applicant: Assure Tech., LLC. Device class: 2.

Clearance details

Applicant: Assure Tech., LLC
Product code: Code NFT
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2025-07-21
Decision date: 2025-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

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K260355 — Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup2026-03-09

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Data sourced from openFDA. This site is unofficial and independent of the FDA.