Medical Device Manufacturer · AU , Windsor

Panbio Limited - FDA 510(k) Cleared Devices

4 submissions · 3 cleared · Since 2003

Recent clearances: WEST NILE VIRUS IGG INDIRECT ELISA, WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M, EBV VCA-P18 IGG ELISA

View 4 510(k) Devices ↓

4

Total

3

Cleared

1

Denied

FDA 510(k) Regulatory Record - Panbio Limited Microbiology ✕

4 devices

1-4 of 4

Cleared Oct 20, 2004

WEST NILE VIRUS IGG INDIRECT ELISA

Microbiology · 177d

Cleared Aug 10, 2004

WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M

Microbiology · 92d

Not Cleared Jul 08, 2003

WEST NILE VIRUS IGM CAPTURE ELISA

DEN030004 · NOP

Microbiology · 5d

Cleared Jun 27, 2003

EBV VCA-P18 IGG ELISA

Microbiology · 101d

Data Source

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

Last updated: Sep 24, 2026