FDA.reportPublic FDA data

510(k) K250727

Device
AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup
Applicant
Hangzhou AllTest Biotech Co., Ltd.
510(k) number
K250727
Product code
NFT
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-04
Date received
2025-03-11
Regulation
862.3100
Classification name
Test, Amphetamine, Over The Counter
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Rosa Wu
Address
#550 Yinhai St. Hangzhou CN 310018 310018

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NFT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261409BioTeke® Multi-Drug Urine Test CupBioteke Corporation (Wuxi) Co., Ltd.2026-09-10
K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupAssure Tech., LLC2026-07-17
K261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelVivachek Biotech (Hangzhou) Co., Ltd.2026-05-22
K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxGuangzhou Wondfo Biotech Co., Ltd.2026-04-28
K260355Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupWEBEST Biotech,, LLC2026-03-09
K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxGuangzhou Wondfo Biotech Co., Ltd.2025-11-18
K252867VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupAdvin Biotech, Inc.2025-10-09
K252554Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupVivachek Biotech (Hangzhou) Co., Ltd.2025-09-12
K252118CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy CupHangzhou Clongene Biotech Co., Ltd.2025-08-27
K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupAssure Tech., LLC2025-08-15
K244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.2025-02-27
K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test CupAssure Tech., LLC2025-02-07
K242498Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTCAicheck Biotech, Inc.2024-10-01
K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.2024-09-27
K242077PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test CupAicheck Biotech, Inc.2024-08-14