Panels › Clinical Toxicology › Product code NFT · Class 2
Test, Amphetamine, Over The Counter
Regulation 862.3100
6510(k)s in 12 months (32 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NFT
| Company | 510(k)s | Recalls |
|---|---|---|
| Guangzhou Wondfo Biotech Co., Ltd. | 4 | 0 |
| Hangzhou AllTest Biotech Co., Ltd. | 4 | 0 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | 4 | 0 |
| Assure Tech., LLC | 3 | 0 |
| Assure Tech. (Hangzhou) Co, Ltd. | 3 | 0 |
| Safecare Biotech (Hangzhou) Co., Ltd. | 3 | 0 |
| Aicheck Biotech, Inc. | 2 | 0 |
| Healstone Biotech, Inc. | 2 | 0 |
| Advin Biotech, Inc. | 1 | 0 |
| Bioteke Corporation (Wuxi) Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2026 | K261409 | BioTeke® Multi-Drug Urine Test Cup Bioteke Corporation (Wuxi) Co., Ltd., CN | NFT |
| Jul 17, 2026 | K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup Assure Tech., LLC | NFT |
| May 22, 2026 | K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel Vivachek Biotech (Hangzhou) Co., Ltd., CN | NFT |
| Apr 28, 2026 | K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx Guangzhou Wondfo Biotech Co., Ltd., CN | NFT |
| Mar 9, 2026 | K260355 | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup WEBEST Biotech,, LLC | NFT |
| Nov 18, 2025 | K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx Guangzhou Wondfo Biotech Co., Ltd., CN | NFT |
| Oct 9, 2025 | K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup Advin Biotech, Inc. | NFT |
| Sep 12, 2025 | K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup Vivachek Biotech (Hangzhou) Co., Ltd., CN | NFT |
| Aug 27, 2025 | K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup Hangzhou Clongene Biotech Co., Ltd., CN | NFT |
| Aug 15, 2025 | K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup Assure Tech., LLC | NFT |
| Apr 4, 2025 | K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup Hangzhou AllTest Biotech Co., Ltd., CN | NFT |
| Feb 27, 2025 | K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup Hangzhou AllTest Biotech Co., Ltd., CN | NFT |
| Feb 7, 2025 | K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Ur Assure Tech., LLC | NFT |
| Oct 1, 2024 | K242498 | Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC Aicheck Biotech, Inc. | NFT |
| Sep 27, 2024 | K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel Hangzhou AllTest Biotech Co., Ltd., CN | NFT |
| Aug 14, 2024 | K242077 | PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup Aicheck Biotech, Inc. | NFT |
| Jun 17, 2024 | K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup Hangzhou AllTest Biotech Co., Ltd., CN | NFT |
| Nov 2, 2023 | K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx Vivachek Biotech (Hangzhou) Co., Ltd., CN | NFT |
| Nov 10, 2022 | K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx Vivachek Biotech (Hangzhou) Co., Ltd., CN | NFT |
| Aug 30, 2022 | K221871 | Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx Healstone Biotech, Inc., CA | NFT |
| May 5, 2022 | K220685 | HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx Qingdao Hightop Biotech Co., Ltd., CN | NFT |
| Mar 24, 2021 | K202453 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card Safecare Biotech (Hangzhou) Co., Ltd., CN | NFT |
| Sep 25, 2020 | K202567 | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx Guangzhou Wondfo Biotech Co., Ltd., CN | NFT |
| May 27, 2020 | K201120 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card Safecare Biotech (Hangzhou) Co., Ltd., CN | NFT |
| Aug 7, 2019 | K191841 | Accurate Multi Panel Drug Urine Test Cup Healstone Biotech, Inc., CA | NFT |
| Dec 3, 2018 | K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup Guangzhou Wondfo Biotech Co., Ltd., CN | NFT |
| Nov 9, 2018 | K182530 | BIOEASY Multi-Drug Test Cup Shenzhen Bioeasy Biotechnology Co., Ltd., CN | NFT |
| Aug 20, 2018 | K181968 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card Safecare Biotech (Hangzhou) Co., Ltd., CN | NFT |
| Aug 20, 2018 | K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Assure Tech. (Hangzhou) Co, Ltd., CN | NFT |
| Apr 5, 2018 | K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Assure Tech. (Hangzhou) Co, Ltd., CN | NFT |
| Feb 5, 2018 | K171695 | First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, F W.H.P.M., Inc. | NFT |
| May 2, 2017 | K170049 | AssureTech Panel Dip Test, AssureTech Quick Cup Test Assure Tech. (Hangzhou) Co, Ltd., CN | NFT |
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