Medical Device Manufacturer · FR , Marcy-L'?toile

Biom?rieux SA - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2020

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Biom?rieux SA Microbiology ✕

2 devices

1-2 of 2

PCCP authorized FDA software change control pathway

Regulatory consultants 510(k) submission support ecosystem

Biomérieux SA

Biomérieux

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 08, 2026