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) 号: K242428
器械名称: 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
申请人: Guangzhou Decheng Biotechnology Co., Ltd. CN
产品代码: NGL — Test, Opiates, Over The Counter
批准日期: 2025-02-06
受理日期: 2024-08-15
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Clinical Toxicology

PDF下载 510(k) Summary本站存档 · 0.5 MB · FDA 公有领域文件

也可从 FDA 官方下载： K242428.pdf

FDA 官方记录： K242428

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。