NGL
- 产品代码
- NGL
- 器械名称
- Test, Opiates, Over The Counter
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 862.3650
- FDA 专业组
- Clinical Toxicology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 18 件
- 其中 Summary 已存档
- 15 份，可直接下载
- FDA 历史累计 510(k)
- 23 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（18 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253567 | 2025-12-23 | Healgen Scientific,, LLC | Healgen Accurate Urine Drug Screen Dip Card; Healgen… | |
| K250803 | 2025-04-15 | Anhui Deepblue Medical Technological C… | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Mu… | |
| K250067 | 2025-02-20 | Guangzhou Decheng Biotechnology Co., L… | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Dru… | |
| K242428 | 2025-02-06 | Guangzhou Decheng Biotechnology Co., L… | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl … | |
| K243365 | 2024-12-17 | Healgen Scientific,, LLC | Healgen Accurate Muti-Drug Urine Drug Screen Cup; He… | |
| K243064 | 2024-11-20 | Eterbio, Inc. | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal G… | |
| K242802 | 2024-11-08 | Hangzhou Clongene Biotech Co., Ltd. | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fenta… | |
| K241869 | 2024-10-04 | Vivachek Biotech (Hangzhou) Co., Ltd. | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fent… | |
| K241969 | 2024-08-14 | Qingdao Hightop Biotech Co., Ltd. | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid T… | FDA |
| K241741 | 2024-07-16 | Guangzhou Wondfo Biotech Co., Ltd. | SAFElife Fentanyl Urine Home Test (Cassette); SAFEl… | FDA |
| K241100 | 2024-05-22 | Co-Innovation Biotech Co., Ltd. | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine F… | |
| K240949 | 2024-05-13 | Healgen Scientific,, LLC | Healgen® Accurate Fentanyl Rapid Test Cassette (Urin… | |
| K240686 | 2024-04-12 | Healgen Scientific,, LLC | Healgen Accurate Urine Drug Screen Dip Card; Healgen… | FDA |
| K240654 | 2024-04-10 | Safecare Biotech (Hangzhou) Co., Ltd. | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL … | |
| K240295 | 2024-03-28 | Instanosis, Inc. | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip F… | |
| K234006 | 2024-03-21 | Allsource Screening Solutions | AllSource Drug Detector FenTest; AllSource Drug Dete… | |
| K240351 | 2024-03-06 | Assure Tech., LLC | FaStep Fentanyl Rapid Test Device (Urine); FaStep Ra… | |
| K233417 | 2023-10-26 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Fentanyl Urine Test Cassette |
FDA 官方分类页： NGL
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。