K240949

Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)

510(k) 号: K240949
器械名称: Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)
申请人: Healgen Scientific,, LLC TX · US
产品代码: NGL — Test, Opiates, Over The Counter
批准日期: 2024-05-13
受理日期: 2024-04-08
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 · 2.6 MB · FDA 公有领域文件

也可从 FDA 官方下载： K240949.pdf

FDA 官方记录： K240949

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。