Medical Device Manufacturer · TW , New Taipei City

Panion & BF Biotech, Inc. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2019

Recent clearances: Vstrip H. pylori Antigen Rapid Test

View 1 510(k) Devices ↓

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Panion & BF Biotech, Inc. Microbiology ✕

1 devices

1-1 of 1

Cleared Mar 14, 2019

Vstrip H. pylori Antigen Rapid Test

Microbiology · 83d

Data Source

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

Last updated: Jun 04, 2026