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Alinity i STAT High Sensitivity Troponin-I

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202525
510(k) Type
Traditional
Applicant
Abbott Laboratories Diagnostics Division
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/19/2022
Days to Decision
625 days
Submission Type
Summary

Alinity i STAT High Sensitivity Troponin-I

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202525
510(k) Type
Traditional
Applicant
Abbott Laboratories Diagnostics Division
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/19/2022
Days to Decision
625 days
Submission Type
Summary