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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K201441
Device Name Elecsys Troponin T Gen 5
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact Jane Phillips
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact Jane Phillips
Regulation Number862.1215
Classification Product Code
MMI  
Date Received06/01/2020
Decision Date 09/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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