NFT
- Product code
- NFT
- Device name
- Test, Amphetamine, Over The Counter
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.3100
- Medical specialty
- Clinical Toxicology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 17
- Summaries archived here
- 15 (direct download)
- 510(k) clearances (all years, FDA)
- 31 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (17)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261984 | 2026-07-17 | Assure Tech., LLC | AssureTech Quick Cup Tests;AssureTech Multi-drug Uri… | FDA |
| K261280 | 2026-05-22 | Vivachek Biotech (Hangzhou) Co., Ltd. | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-… | |
| K260065 | 2026-04-28 | Guangzhou Wondfo Biotech Co., Ltd. | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife… | |
| K260355 | 2026-03-09 | WEBEST Biotech,, LLC | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug … | |
| K252550 | 2025-11-18 | Guangzhou Wondfo Biotech Co., Ltd. | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T… | |
| K252867 | 2025-10-09 | Advin Biotech, Inc. | VINScreen Urine Drug Test Cup; VINScreen Urine Drug … | |
| K252554 | 2025-09-12 | Vivachek Biotech (Hangzhou) Co., Ltd. | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Dru… | |
| K252118 | 2025-08-27 | Hangzhou Clongene Biotech Co., Ltd. | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Dr… | FDA |
| K252259 | 2025-08-15 | Assure Tech., LLC | AssureTech Quick Cup Tests; AssureTech Multi-drug Ur… | |
| K250727 | 2025-04-04 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Mul… | |
| K244043 | 2025-02-27 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Dr… | |
| K243996 | 2025-02-07 | Assure Tech., LLC | AssureTech Panel Dip Tests; AssureTech Quick Cup Tes… | |
| K242498 | 2024-10-01 | Aicheck Biotech, Inc. | Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug … | |
| K242540 | 2024-09-27 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Multi-Drug Urine Test Panel; AllTest Multi-D… | |
| K242077 | 2024-08-14 | Aicheck Biotech, Inc. | PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi… | |
| K241428 | 2024-06-17 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Dr… | |
| K233062 | 2023-11-02 | Vivachek Biotech (Hangzhou) Co., Ltd. | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM M… |
Official FDA classification page: NFT
Classification and pathway per current FDA publications. Data from openFDA (CC0).