AssureTech Panel Dip Tests +3 more— 510(k) K243996

Name: FDA 510(k) clearance K243996
Creator: U.S. Food and Drug Administration
Published: 2025-02-07

Substantially Equivalent

Assure Tech., LLC

FDA 510(k) clearance K243996 for AssureTech Panel Dip Tests +3 more, Substantially Equivalent on 2025-02-07. Applicant: Assure Tech., LLC. Device class: 2.

Clearance details

Device name as filed: AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup
Applicant: Assure Tech., LLC
Product code: Code NFT
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2024-12-26
Decision date: 2025-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NFT

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K261409 — BioTeke® Multi-Drug Urine Test Cup2026-09-10
K261984 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup2026-07-17
K261280 — BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel2026-05-22
K260065 — SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx2026-04-28
K260355 — Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup2026-03-09

More clearances from Assure Tech., LLC

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K260754 — Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test2026-06-05
K252259 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup2025-08-15
K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette2025-02-13
K243573 — FaStep Early Pregnancy Rapid Test Strip +2 more2025-01-15
K240351 — FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)2024-03-06

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