| AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup (K261984) | Assure Tech., LLC | 2026-07-17 |
| BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel (K261280) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026-05-22 |
| SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx (K260065) | Guangzhou Wondfo Biotech Co., Ltd. | 2026-04-28 |
| Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup (K260355) | WEBEST Biotech,, LLC | 2026-03-09 |
| SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx (K252550) | Guangzhou Wondfo Biotech Co., Ltd. | 2025-11-18 |
| VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup (K252867) | Advin Biotech, Inc. | 2025-10-09 |
| Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup (K252554) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2025-09-12 |
| CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup (K252118) | Hangzhou Clongene Biotech Co., Ltd. | 2025-08-27 |
| AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup (K252259) | Assure Tech., LLC | 2025-08-15 |
| AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup (K250727) | Hangzhou AllTest Biotech Co., Ltd. | 2025-04-04 |
| AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (K244043) | Hangzhou AllTest Biotech Co., Ltd. | 2025-02-27 |
| AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup (K243996) | Assure Tech., LLC | 2025-02-07 |
| Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC (K242498) | Aicheck Biotech, Inc. | 2024-10-01 |
| AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel (K242540) | Hangzhou AllTest Biotech Co., Ltd. | 2024-09-27 |
| PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup (K242077) | Aicheck Biotech, Inc. | 2024-08-14 |
| AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup (K241428) | Hangzhou AllTest Biotech Co., Ltd. | 2024-06-17 |
| BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx (K233062) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-11-02 |
| Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx (K222667) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2022-11-10 |
| Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx (K221871) | Healstone Biotech, Inc. | 2022-08-30 |
| HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx (K220685) | Qingdao Hightop Biotech Co., Ltd. | 2022-05-05 |
| SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (K202453) | Safecare Biotech (Hangzhou) Co., Ltd. | 2021-03-24 |
| Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx (K202567) | Guangzhou Wondfo Biotech Co., Ltd. | 2020-09-25 |
| SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (K201120) | Safecare Biotech (Hangzhou) Co., Ltd. | 2020-05-27 |
| Accurate Multi Panel Drug Urine Test Cup (K191841) | Healstone Biotech, Inc. | 2019-08-07 |
| Wondfo T-Cup Multi-Drug Urine Test Cup (K182701) | Guangzhou Wondfo Biotech Co., Ltd. | 2018-12-03 |
| BIOEASY Multi-Drug Test Cup (K182530) | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2018-11-09 |
| AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (K181768) | Assure Tech. (Hangzhou) Co, Ltd. | 2018-08-20 |
| SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (K181968) | Safecare Biotech (Hangzhou) Co., Ltd. | 2018-08-20 |
| AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (K180349) | Assure Tech. (Hangzhou) Co, Ltd. | 2018-04-05 |
| 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 (K171695) | W.H.P.M., Inc. | 2018-02-05 |
| AssureTech Panel Dip Test, AssureTech Quick Cup Test (K170049) | Assure Tech. (Hangzhou) Co, Ltd. | 2017-05-02 |