Last synced on 14 November 2025 at 11:06 pm

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay

Page Type
Cleared 510(K)
510(k) Number
K190675
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/17/2019
Days to Decision
63 days
Submission Type
Summary

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay

Page Type
Cleared 510(K)
510(k) Number
K190675
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/17/2019
Days to Decision
63 days
Submission Type
Summary