Medical Device Manufacturer · SE , S-17136 Solna, Sweden

Ab Biodisk North America, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1994

Recent clearances: SYSTEM U3 FOR GENTAMICIN, AMOXICILLIN/CLAVULANIC ACID 2/1, ETEST FOR AMPICILLIN/SULBACTAM 2/1

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ab Biodisk North America, Inc. Microbiology ✕

3 devices

1-3 of 3

Cleared Nov 20, 1998

SYSTEM U3 FOR GENTAMICIN

Microbiology · 65d

Cleared Apr 14, 1995

AMOXICILLIN/CLAVULANIC ACID 2/1

Microbiology · 85d

Cleared Nov 04, 1994

ETEST FOR AMPICILLIN/SULBACTAM 2/1

Microbiology · 351d