Medical Device Manufacturer · US , Hazelwood , MO

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

2 submissions · 2 cleared · Since 2022

Recent clearances: VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL), VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)

View 2 510(k) Devices ↓
2
Total
2
Cleared
0
Denied

Biom?rieux, Inc. has 2 FDA 510(k) cleared medical devices. Based in Hazelwood, US.

Latest FDA clearance: Sep 2026. Active since 2022. Primary specialty: Microbiology.

Browse the FDA 510(k) cleared devices submitted by Biom?rieux, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Biomérieux, Inc. as regulatory consultant. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

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

2 devices
1-2 of 2
Cleared Sep 28, 2026
VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)
K260619 · LON
Microbiology · 215d
Cleared Feb 04, 2022
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
K212849 · LON
Microbiology · 150d
Filters
Filter by Specialty
All2 Microbiology 2