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ADVIA Centaur High-Sensitivity Troponin I (TNIH)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171274
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/12/2018
Days to Decision
437 days
Submission Type
Summary

ADVIA Centaur High-Sensitivity Troponin I (TNIH)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K171274
510(k) Type
Traditional
Applicant
Siemens Healthcare Diagnostics Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/12/2018
Days to Decision
437 days
Submission Type
Summary