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

Biom?rieux - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2023

2

Total

2

Cleared

0

Denied

FDA 510(k) cleared devices by Biom?rieux Microbiology ✕

2 devices

1-2 of 2

Cleared Jun 12, 2025

ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)

Microbiology · 83d

Cleared Oct 05, 2023

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD

Microbiology · 57d