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Dimension Vista High-Sensitivity Troponin I (TNIH) Assay

Page Type
Cleared 510(K)
510(k) Number
K182225
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/4/2019
Days to Decision
200 days
Submission Type
Summary

Dimension Vista High-Sensitivity Troponin I (TNIH) Assay

Page Type
Cleared 510(K)
510(k) Number
K182225
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/4/2019
Days to Decision
200 days
Submission Type
Summary