Medical Device Manufacturer · CN , Wuxi City

Bioteke Corporation (Wuxi) Co., Ltd. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2022

Recent clearances: BioTeke® Multi-Drug Urine Test Cup, BioTeke Sterile Disposable Virus Sampling Kit

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bioteke Corporation (Wuxi) Co., Ltd. Toxicology ✕

1 devices

1-1 of 1

Cleared Sep 10, 2026

BioTeke® Multi-Drug Urine Test Cup

Toxicology · 133d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Oct 05, 2026