FDA 510(k) Applications for Medical Device Product Code "NFT"
(Test, Amphetamine, Over The Counter)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K242498 | Aicheck Biotech, Inc. | Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC | 10/01/2024 |
| K242077 | Aicheck Biotech, Inc. | PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup | 08/14/2024 |
| K170049 | ASSURE TECH (HANGZHOU) CO., LTD. | AssureTech Panel Dip Test, AssureTech Quick Cup Test | 05/02/2017 |
| K181768 | Assure Tech (Hangzhou) Co., Ltd. | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | 08/20/2018 |
| K180349 | Assure Tech (Hangzhou) Co., Ltd. | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | 04/05/2018 |
| K243996 | Assure Tech LLC | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup | 02/07/2025 |
| K182701 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo T-Cup Multi-Drug Urine Test Cup | 12/03/2018 |
| K202567 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx | 09/25/2020 |
| K244043 | Hangzhou Alltest Biotech Co.,Ltd | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | 02/27/2025 |
| K250727 | Hangzhou Alltest Biotech Co.,Ltd | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | 04/04/2025 |
| K241428 | Hangzhou Alltest Biotech Co.,Ltd | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | 06/17/2024 |
| K242540 | Hangzhou Alltest Biotech Co.,Ltd | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | 09/27/2024 |
| K191841 | Healstone Biotech Inc | Accurate Multi Panel Drug Urine Test Cup | 08/07/2019 |
| K221871 | Healstone Biotech Inc | Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx | 08/30/2022 |
| K220685 | Qingdao HIGHTOP Biotech Co., Ltd. | HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx | 05/05/2022 |
| K201120 | Safecare Biotech(Hangzhou)Co.,Ltd. | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | 05/27/2020 |
| K181968 | Safecare Biotech(Hangzhou)Co.,Ltd. | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | 08/20/2018 |
| K202453 | Safecare Biotech(Hangzhou)Co.,Ltd. | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card | 03/24/2021 |
| K182530 | Shenzhen Bioeasy Biotechnology Co.,Ltd. | BIOEASY Multi-Drug Test Cup | 11/09/2018 |
| K233062 | VivaChek Biotech (Hangzhou) Co., Ltd | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx | 11/02/2023 |
| K222667 | Vivachek Biotech (Hangzhou) Co., Ltd | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx | 11/10/2022 |
| K171695 | W.H.P.M., Inc. | 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 | 02/05/2018 |
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