BioTeke® Multi-Drug Urine Test Cup— 510(k) K261409
Substantially EquivalentBioteke Corporation (Wuxi) Co., Ltd.
FDA 510(k) clearance K261409 for BioTeke® Multi-Drug Urine Test Cup, Substantially Equivalent on 2026-09-10. Applicant: Bioteke Corporation (Wuxi) Co., Ltd.. Device class: 2.
Summary
The BioTeke Multi-Drug Urine Test Cup is filed under NFT, over-the-counter amphetamine tests. Going by the name, it tests urine for more than one drug, but the record doesn't list the others.
Class II, 21 CFR 862.3100. The Clinical Toxicology panel reviewed it as a Traditional 510(k).
Bioteke Corporation filed from Wuxi, China. Review took 133 days (April 30 to September 10, 2026).
Clearance details
- Applicant
- Bioteke Corporation (Wuxi) Co., Ltd.
- Product code
- Product code NFT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wuxi, CN
Recent devices under product code NFT
view all- K261984 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
- K261280 — BioSieve Multi-Drug Urine Test Panel; BioSieve Multi-Drug Urine Home Test Panel
- K260065 — SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx
- K260355 — Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup
- K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
More clearances from Bioteke Corporation (Wuxi) Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.