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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
K171566
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/19/2018
Days to Decision
415 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
K171566
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/19/2018
Days to Decision
415 days
Submission Type
Summary