Last synced on 14 November 2025 at 11:06 pm

Alinity i STAT High Sensitivity Troponin-I

Page Type
Cleared 510(K)
510(k) Number
K230994
510(k) Type
Special
Applicant
Abbott Laboratories Diagnostics Division
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/4/2023
Days to Decision
27 days
Submission Type
Summary

Alinity i STAT High Sensitivity Troponin-I

Page Type
Cleared 510(K)
510(k) Number
K230994
510(k) Type
Special
Applicant
Abbott Laboratories Diagnostics Division
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/4/2023
Days to Decision
27 days
Submission Type
Summary