FDA Product Code
FDA Product Code NFT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Toxicology
- 21 CFR Citation
- 862.3100
510(k) Clearances — 32 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261409 | BioTeke® Multi-Drug Urine Test Cup | Bioteke Corporation (Wuxi) Co., Ltd. | 2026-09-10 | Traditional | PDF ↗ |
| K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC | 2026-07-17 | Traditional | PDF ↗ |
| K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026-05-22 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K260355 | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup | WEBEST Biotech,, LLC | 2026-03-09 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup | Advin Biotech, Inc. | 2025-10-09 | Traditional | PDF ↗ |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | Vivachek Biotech (Hangzhou) Co., Ltd. | 2025-09-12 | Traditional | PDF ↗ |
| K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup | Hangzhou Clongene Biotech Co., Ltd. | 2025-08-27 | Traditional | PDF ↗ |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC | 2025-08-15 | Traditional | PDF ↗ |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 | Traditional | PDF ↗ |
| K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2025-02-27 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K242498 | Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC | Aicheck Biotech, Inc. | 2024-10-01 | Traditional | PDF ↗ |
| K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | 2024-09-27 | Traditional | PDF ↗ |
| K242077 | PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup | Aicheck Biotech, Inc. | 2024-08-14 | Traditional | PDF ↗ |
| K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2024-06-17 | Traditional | PDF ↗ |
| K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-11-02 | Traditional | PDF ↗ |
| K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx | Vivachek Biotech (Hangzhou) Co., Ltd. | 2022-11-10 | Traditional | PDF ↗ |
| K221871 | Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx | Healstone Biotech, Inc. | 2022-08-30 | Traditional | PDF ↗ |
| K220685 | HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx | Qingdao Hightop Biotech Co., Ltd. | 2022-05-05 | Traditional | PDF ↗ |
| K202453 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | Safecare Biotech (Hangzhou) Co., Ltd. | 2021-03-24 | Traditional | PDF ↗ |
| K202567 | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx | Guangzhou Wondfo Biotech Co., Ltd. | 2020-09-25 | Traditional | PDF ↗ |
| K201120 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | Safecare Biotech (Hangzhou) Co., Ltd. | 2020-05-27 | Traditional | PDF ↗ |
| K191841 | Accurate Multi Panel Drug Urine Test Cup | Healstone Biotech, Inc. | 2019-08-07 | Traditional | PDF ↗ |
| K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2018-12-03 | Traditional | PDF ↗ |
| K182530 | BIOEASY Multi-Drug Test Cup | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2018-11-09 | Traditional | PDF ↗ |
| K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018-08-20 | Traditional | PDF ↗ |
| K181968 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | Safecare Biotech (Hangzhou) Co., Ltd. | 2018-08-20 | Traditional | PDF ↗ |
| K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018-04-05 | Traditional | PDF ↗ |
| K171695 | First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana | W.H.P.M., Inc. | 2018-02-05 | Traditional | PDF ↗ |
| K170049 | AssureTech Panel Dip Test, AssureTech Quick Cup Test | Assure Tech. (Hangzhou) Co, Ltd. | 2017-05-02 | Traditional | PDF ↗ |
Product code NFT · Class II · Clinical Toxicology. Data: openFDA.