Medical Device Manufacturer · IE , Longford

Abbott Ireland Diagnostics Division - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2021

Recent clearances: Alkaline Phosphatase2, Total Bilirubin2, Cholesterol2

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Abbott Ireland Diagnostics Division Chemistry ✕

8 devices

1-8 of 8

Cleared Jul 21, 2023

Alkaline Phosphatase2

Chemistry · 266d

Cleared Dec 29, 2022

Total Bilirubin2

Chemistry · 59d

Cleared Jun 30, 2022

Chemistry · 568d

Cleared May 31, 2022

Chemistry · 524d

Cleared May 26, 2022

Chemistry · 449d

Cleared Mar 22, 2022

Chemistry · 399d

Cleared Mar 18, 2022

Chemistry · 471d

Cleared Nov 23, 2021

Chemistry · 384d