Abbott Laboratories Diagnostics Division

Medical device manufacturer in Irving, TX.

4510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K240468Alkaline PhosphataseCJE · Special 10/16/2024SE
K230994Alinity i STAT High Sensitivity Troponin-IMMI · Special 05/04/2023SE
K202525Alinity i STAT High Sensitivity Troponin-IMMI · Traditional 05/19/2022SE
K191595ARCHITECT STAT High Sensitivity Troponin-IMMI · Traditional 09/13/2019SE