Medical Device Manufacturer · US , Hazelwood , MO

Biom?rieux, Inc. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2022

Recent clearances: VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biom?rieux, Inc. Microbiology ✕

1 devices

1-1 of 1

Cleared Feb 04, 2022

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)

Microbiology · 150d

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 21, 2026