FDA.reportPublic FDA data

510(k) K221871

Device
Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
Applicant
Healstone Biotech, Inc.
510(k) number
K221871
Product code
NFT
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-30
Date received
2022-06-28
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
Bryan Fang
Address
Unit 650 - 655 W. Kent Ave. N. Vancouver CA V6P 6T7 V6P 6T7

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
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
K250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.2025-04-04
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
K241428AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.2024-06-17