Last synced on 25 January 2026 at 3:41 am

Atellica® IM High-Sensitivity Troponin I (TnIH)

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241165
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/25/2024
Days to Decision
90 days
Submission Type
Summary

Atellica® IM High-Sensitivity Troponin I (TnIH)

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241165
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/25/2024
Days to Decision
90 days
Submission Type
Summary