Abbott Laboratories Diagnostics Division

FDA Regulatory Profile

Abbott Laboratories Diagnostics Division appears in FDA public data with 0 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on October 16, 2024.

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K240468Alkaline PhosphataseOctober 16, 2024
K230994Alinity i STAT High Sensitivity Troponin-IMay 4, 2023
K202525Alinity i STAT High Sensitivity Troponin-IMay 19, 2022
K191595ARCHITECT STAT High Sensitivity Troponin-ISeptember 13, 2019