NFT

Test, Amphetamine, Over The Counter

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)

数据窗口为最近三年。最新一件:2026-07-17。

510(k) 号批准日期申请人器械名称摘要
K2619842026-07-17Assure Tech., LLCAssureTech Quick Cup Tests;AssureTech Multi-drug Uri…FDA
K2612802026-05-22Vivachek Biotech (Hangzhou) Co., Ltd.BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-…PDF
K2600652026-04-28Guangzhou Wondfo Biotech Co., Ltd.SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife…PDF
K2603552026-03-09WEBEST Biotech,, LLCWebest Multi-Drug Urine Cup; Webest Home Multi-Drug …PDF
K2525502025-11-18Guangzhou Wondfo Biotech Co., Ltd.SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T…PDF
K2528672025-10-09Advin Biotech, Inc.VINScreen Urine Drug Test Cup; VINScreen Urine Drug …PDF
K2525542025-09-12Vivachek Biotech (Hangzhou) Co., Ltd.Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Dru…PDF
K2521182025-08-27Hangzhou Clongene Biotech Co., Ltd.CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Dr…FDA
K2522592025-08-15Assure Tech., LLCAssureTech Quick Cup Tests; AssureTech Multi-drug Ur…PDF
K2507272025-04-04Hangzhou AllTest Biotech Co., Ltd.AllTest Multi-Drug Rapid Urine Test Cup; AllTest Mul…PDF
K2440432025-02-27Hangzhou AllTest Biotech Co., Ltd.AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Dr…PDF
K2439962025-02-07Assure Tech., LLCAssureTech Panel Dip Tests; AssureTech Quick Cup Tes…PDF
K2424982024-10-01Aicheck Biotech, Inc.Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug …PDF
K2425402024-09-27Hangzhou AllTest Biotech Co., Ltd.AllTest Multi-Drug Urine Test Panel; AllTest Multi-D…PDF
K2420772024-08-14Aicheck Biotech, Inc.PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi…PDF
K2414282024-06-17Hangzhou AllTest Biotech Co., Ltd.AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Dr…PDF
K2330622023-11-02Vivachek Biotech (Hangzhou) Co., Ltd.BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM M…PDF

其中 15 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

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。