NFT — Test, Amphetamine, Over The Counter Class II
FDA product code NFT covers "Test, Amphetamine, Over The Counter", a Class II medical device regulated under 21 CFR 862.3100. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NFT
- Device Class
- Class II
- Regulation Number
- 862.3100
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261984 | assure tech | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup | July 17, 2026 |
| K261280 | vivachek biotech (hangzhou) co | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel | May 22, 2026 |
| K260065 | guangzhou wondfo biotech co | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test | April 28, 2026 |
| K260355 | webest biotech | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup | March 9, 2026 |
| K252550 | guangzhou wondfo biotech co | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test C | November 18, 2025 |
| K252867 | advin biotech | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup | October 9, 2025 |
| K252554 | vivachek biotech (hangzhou) co | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | September 12, 2025 |
| K252118 | hangzhou clongene biotech co | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup | August 27, 2025 |
| K252259 | assure tech | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup | August 15, 2025 |
| K250727 | hangzhou alltest biotech co | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | April 4, 2025 |
| K244043 | hangzhou alltest biotech co | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | February 27, 2025 |
| K243996 | assure tech | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Ur | February 7, 2025 |
| K242498 | aicheck biotech | Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC | October 1, 2024 |
| K242540 | hangzhou alltest biotech co | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | September 27, 2024 |
| K242077 | aicheck biotech | PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup | August 14, 2024 |
| K241428 | hangzhou alltest biotech co | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | June 17, 2024 |
| K233062 | vivachek biotech (hangzhou) co | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel R | November 2, 2023 |
| K222667 | vivachek biotech (hangzhou) co | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx | November 10, 2022 |
| K221871 | healstone biotech | Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Dr | August 30, 2022 |
| K220685 | qingdao hightop biotech co | HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx | May 5, 2022 |