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Atellica® IM 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
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
FDA Hosted 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