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Elecsys Troponin T Gen 5

Page Type
Cleared 510(K)
510(k) Number
K201441
510(k) Type
Traditional
Applicant
Roche Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/21/2021
Days to Decision
477 days
Submission Type
Summary

Elecsys Troponin T Gen 5

Page Type
Cleared 510(K)
510(k) Number
K201441
510(k) Type
Traditional
Applicant
Roche Diagnostics
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/21/2021
Days to Decision
477 days
Submission Type
Summary