Product code NFT
- Device name
- Test, Amphetamine, Over The Counter
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3100
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261409 | BioTeke® Multi-Drug Urine Test Cup | Bioteke Corporation (Wuxi) Co., Ltd. | 2026-09-10 |
| K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC | 2026-07-17 |
| 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 |
| K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-11-02 |
| K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx | Vivachek Biotech (Hangzhou) Co., Ltd. | 2022-11-10 |
| 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 |
| K220685 | HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx | Qingdao Hightop Biotech Co., Ltd. | 2022-05-05 |
| K202453 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | Safecare Biotech (Hangzhou) Co., Ltd. | 2021-03-24 |
| 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 |
| K201120 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | Safecare Biotech (Hangzhou) Co., Ltd. | 2020-05-27 |
| K191841 | Accurate Multi Panel Drug Urine Test Cup | Healstone Biotech, Inc. | 2019-08-07 |
| K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2018-12-03 |
| K182530 | BIOEASY Multi-Drug Test Cup | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2018-11-09 |
| K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018-08-20 |
| K181968 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | Safecare Biotech (Hangzhou) Co., Ltd. | 2018-08-20 |
| K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018-04-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06937339211538 | BioSieve | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026-10-14 |
| 06937339211507 | BioSieve | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026-10-14 |
| 06974541566049 | BioTeke | Bioteke Corporation (Wuxi) Co., Ltd. | 2026-10-13 |
| 06936983114028 | Alltest AMP500 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114196 | Alltest AMP500 Rapid Test Dipstick (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114455 | Alltest AMP500 Rapid Test Panel (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114592 | Alltest AMP500 Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983114608 | Alltest AMP500 Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-21 |
| 06936983113878 | Alltest AMP500 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-17 |
| 06936983114868 | Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 06936983125123 | Multi-Drug 12 Drugs Rapid Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 06936983118071 | Alltest Multi-Drug 12 Drugs Home Rapid Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 06936983118064 | Alltest Multi-Drug 12 Drugs Home Rapid Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 06936983114875 | Alltest Multi-Drug 15 Drugs Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 06936983114844 | Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 06936983114837 | Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 06936983114820 | Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 06936983114813 | Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 06936983114806 | Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 06936983114790 | Alltest Multi-Drug 15 Drugs Rapid Test Panel (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 06936983165013 | Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-15 |
| 06936983165020 | Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-15 |
| 06936983169714 | Multi-Drug 12 Drugs Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-15 |
| 06936983169721 | Multi-Drug 12 Drugs Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-15 |
| 06936983169738 | Multi-Drug 12 Drugs Rapid Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-15 |
| 06936983171076 | Alltest Multi-Drug Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-15 |
| 06936983172035 | Alltest Multi-Drug 6 Drugs Rapid Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-15 |
| 06936983197571 | DrugTect Multi-Drug Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-13 |
| 06936983197588 | DrugTect Multi-Drug Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-13 |
| 06936983197595 | DrugTect Multi-Drug Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-13 |