Cleared Traditional

FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)

K240351 · Assure Tech., LLC · Toxicology
Mar 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K240351 is an FDA 510(k) clearance for the FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine), a Test, Opiates, Over The Counter (Class II — Special Controls, product code NGL), submitted by Assure Tech., LLC (Wilmington, US). The FDA issued a Cleared decision on March 6, 2024, 30 days after receiving the submission on February 5, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K240351 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2024
Decision Date March 06, 2024
Days to Decision 30 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code NGL — Test, Opiates, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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