BioTeke® Multi-Drug Urine Test Cup
FDA 510(k) K261409 · Bioteke Corporation (Wuxi) Co., Ltd.
510(k) numberK261409
Submission
- Device name
- BioTeke® Multi-Drug Urine Test Cup
- Applicant
- Bioteke Corporation (Wuxi) Co., Ltd.
Wuxi, CN - Received
- April 30, 2026
- Decision date
- September 10, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NFT – Test, Amphetamine, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
Other 510(k)s with product code NFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupNFT · Traditional | Assure Tech., LLC | 07/17/2026SE |
| K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelNFT · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 05/22/2026SE |
| K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxNFT · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 04/28/2026SE |
| K260355 | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupNFT · Traditional | WEBEST Biotech,, LLC | 03/09/2026SE |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxNFT · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 11/18/2025SE |
| K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupNFT · Traditional | Advin Biotech, Inc. | 10/09/2025SE |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupNFT · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 09/12/2025SE |
| K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy CupNFT · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 08/27/2025SE |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT · Traditional | Assure Tech., LLC | 08/15/2025SE |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupNFT · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 04/04/2025SE |
More from Hangzhou AllTest Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K211707 | BioTeke Sterile Disposable Virus Sampling KitJSM · Traditional | 05/04/2022SE |
Questions and answers
When was BioTeke® Multi-Drug Urine Test Cup cleared by the FDA?
BioTeke® Multi-Drug Urine Test Cup (K261409) received a 510(k) decision of Substantially Equivalent on September 10, 2026, 133 days after the submission was received.
What is the product code of K261409?
The FDA product code is NFT – Test, Amphetamine, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3100.