510(k) clearance
BioTeke® Multi-Drug Urine Test Cup
- 510(k) number
- K261409
- Applicant
- Bioteke Corporation (Wuxi) Co., Ltd.
- Decision date
- Sep 10, 2026
- Date received
- Apr 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NFT
- Device type
- Test, Amphetamine, Over The Counter
- Device class
- Class II
- Regulation
- 21 CFR 862.3100
- Advisory committee
- Clinical Toxicology
- Statement or summary
- Summary
- Third party
- N
- Location
- Wuxi, CN