Medical Device Manufacturer · US , Hazelwood , MO

Biomerieux Sa, Inc. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2023

Recent clearances: VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biomerieux Sa, Inc. Microbiology ✕

1 devices

1-1 of 1

Cleared Mar 09, 2023

VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN...

Microbiology · 210d