K232736

Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test

510(k) 号: K232736
器械名称: Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test
申请人: Chemtron Biotech, Inc. CA · US
产品代码: DJG — Enzyme Immunoassay, Opiates
批准日期: 2023-12-20
受理日期: 2023-09-07
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 · 2.9 MB · FDA 公有领域文件

也可从 FDA 官方下载： K232736.pdf

FDA 官方记录： K232736

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。