FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)— 510(k) K240351

Name: FDA 510(k) clearance K240351
Creator: U.S. Food and Drug Administration
Published: 2024-03-06

Substantially Equivalent

Assure Tech., LLC

FDA 510(k) clearance K240351 for FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine), Substantially Equivalent on 2024-03-06. Applicant: Assure Tech., LLC. Device class: 2.

Clearance details

Applicant: Assure Tech., LLC
Product code: Code NGL
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2024-02-05
Decision date: 2024-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

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