Cleared Traditional

SAFElife? Fentanyl Urine Home Test (Cassette); SAFElife? Fentanyl (FTY) Urine Test Cassette; SAFElife? T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife? T-Dip Fentanyl (FTY) Urine Test Panel

K241741 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology
Jul 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K241741 is an FDA 510(k) clearance for the SAFElife? Fentanyl Urine Home Test (Cassette); SAFElife? Fentanyl (FTY) Urine Test Cassette; SAFElife? T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife? T-Dip Fentanyl (FTY) Urine Test Panel, a Test, Opiates, Over The Counter (Class II — Special Controls, product code NGL), submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on July 16, 2024, 29 days after receiving the submission on June 17, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K241741 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2024
Decision Date July 16, 2024
Days to Decision 29 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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