K242428

Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus

510(k) number: K242428
Device name: Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus
Applicant: Guangzhou Decheng Biotechnology Co., Ltd. CN
Product code: NGL — Test, Opiates, Over The Counter
Decision date: 2025-02-06
Date received: 2024-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Clinical Toxicology

PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K242428.pdf

Official FDA record: K242428

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.