NFT
- 产品代码
- NFT
- 器械名称
- Test, Amphetamine, Over The Counter
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 862.3100
- 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)
- 17 件
- 其中 Summary 已存档
- 15 份,可直接下载
- FDA 历史累计 510(k)
- 31 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)(17 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261984 | 2026-07-17 | Assure Tech., LLC | AssureTech Quick Cup Tests;AssureTech Multi-drug Uri… | FDA |
| K261280 | 2026-05-22 | Vivachek Biotech (Hangzhou) Co., Ltd. | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-… | |
| K260065 | 2026-04-28 | Guangzhou Wondfo Biotech Co., Ltd. | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife… | |
| K260355 | 2026-03-09 | WEBEST Biotech,, LLC | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug … | |
| K252550 | 2025-11-18 | Guangzhou Wondfo Biotech Co., Ltd. | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T… | |
| K252867 | 2025-10-09 | Advin Biotech, Inc. | VINScreen Urine Drug Test Cup; VINScreen Urine Drug … | |
| K252554 | 2025-09-12 | Vivachek Biotech (Hangzhou) Co., Ltd. | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Dru… | |
| K252118 | 2025-08-27 | Hangzhou Clongene Biotech Co., Ltd. | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Dr… | FDA |
| K252259 | 2025-08-15 | Assure Tech., LLC | AssureTech Quick Cup Tests; AssureTech Multi-drug Ur… | |
| K250727 | 2025-04-04 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Mul… | |
| K244043 | 2025-02-27 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Dr… | |
| K243996 | 2025-02-07 | Assure Tech., LLC | AssureTech Panel Dip Tests; AssureTech Quick Cup Tes… | |
| K242498 | 2024-10-01 | Aicheck Biotech, Inc. | Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug … | |
| K242540 | 2024-09-27 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Multi-Drug Urine Test Panel; AllTest Multi-D… | |
| K242077 | 2024-08-14 | Aicheck Biotech, Inc. | PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi… | |
| K241428 | 2024-06-17 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Dr… | |
| K233062 | 2023-11-02 | Vivachek Biotech (Hangzhou) Co., Ltd. | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM M… |
FDA 官方分类页: NFT
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。