Medical Device Manufacturer · US , Abbott Park , IL

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

4 submissions · 4 cleared · Since 2019

Recent clearances: Alkaline Phosphatase, Alinity i STAT High Sensitivity Troponin-I, Alinity i STAT High Sensitivity Troponin-I

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Oct 16, 2024

Alkaline Phosphatase

Chemistry · 239d

Cleared May 04, 2023

Alinity i STAT High Sensitivity Troponin-I

Chemistry · 27d

Cleared May 19, 2022

Alinity i STAT High Sensitivity Troponin-I

Chemistry · 625d

Cleared CT Sep 13, 2019

ARCHITECT STAT High Sensitivity Troponin-I

Chemistry · 88d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: May 10, 2026