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ARCHITECT 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
K191595
510(k) Type
Traditional
Applicant
Abbott Laboratories Diagnostics Division
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/13/2019
Days to Decision
88 days
Submission Type
Summary

ARCHITECT 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
K191595
510(k) Type
Traditional
Applicant
Abbott Laboratories Diagnostics Division
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/13/2019
Days to Decision
88 days
Submission Type
Summary