Medical Device Manufacturer · SE , Solna

Ab Biomerieux - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2009

Recent clearances: ETEST MOXIFLOXACIN 0.002-32 UG/ML, ETEST VORICONAZOLE 0.002-32 UG/ML

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ab Biomerieux Microbiology ✕

2 devices

1-2 of 2

Cleared Aug 25, 2010

ETEST MOXIFLOXACIN 0.002-32 UG/ML

Microbiology · 278d

Cleared Nov 02, 2009

ETEST VORICONAZOLE 0.002-32 UG/ML

Microbiology · 426d