DeviceClearance

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

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.

Clearance details

Applicant
Assure Tech., LLC
Product code
Code NGL
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wilmington, DE, US
Download summary PDFView on FDA.gov ↗

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