510(k) K233062

Device: BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
510(k) number: K233062
Product code: NFT
Decision: Substantially Equivalent (SESE)
Decision date: 2023-11-02
Date received: 2023-09-26
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

Related Records

Applicant Contact

Contact: Jessica Chen
Address: Level 2, Block 2, 146 E. Chaofeng Rd. Yuhang Economy Development Zone Hangzhou CN 311100 311100

FDA Registration Numbers

1910144
3012725363
3014301129
3006048451
3015821396
3005360469
3036649420
3043127647
2087033
3011522054
3009414546
3007606081
3009585529
3023296261
3030413233
3010934853
3017904598
2060833
3013077867
3005345870
3008741972
1649661
3010220539
3016447251
3032147516
3024463179
3021186226
3010852191
3025041446
3043196750
3030648160
3024753119
3008517993
3012073813
3005984081
3009238284
3013223546
3038614708
3003917514
3004635103
3031697086
3014223276
2029372
2030633
3009212837
3025349997
3027519599
3023322455

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code NFT

510(k)	Device	Applicant	Decision date
K261280	BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel	Vivachek Biotech (Hangzhou) Co., Ltd.	2026-05-22
K260065	SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx	Guangzhou Wondfo Biotech Co., Ltd.	2026-04-28
K260355	Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup	WEBEST Biotech,, LLC	2026-03-09
K252550	SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx	Guangzhou Wondfo Biotech Co., Ltd.	2025-11-18
K252867	VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup	Advin Biotech, Inc.	2025-10-09
K252554	Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup	Vivachek Biotech (Hangzhou) Co., Ltd.	2025-09-12
K252118	CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup	Hangzhou Clongene Biotech Co., Ltd.	2025-08-27
K252259	AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup	Assure Tech., LLC	2025-08-15
K250727	AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup	Hangzhou AllTest Biotech Co., Ltd.	2025-04-04
K244043	AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup	Hangzhou AllTest Biotech Co., Ltd.	2025-02-27
K243996	AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup	Assure Tech., LLC	2025-02-07
K242498	Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC	Aicheck Biotech, Inc.	2024-10-01
K242540	AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel	Hangzhou AllTest Biotech Co., Ltd.	2024-09-27
K242077	PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup	Aicheck Biotech, Inc.	2024-08-14
K241428	AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup	Hangzhou AllTest Biotech Co., Ltd.	2024-06-17