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510(k) K201441

Elecsys Troponin T Gen 5 by Roche Diagnostics — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2021
Date Received
June 1, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoassay Method, Troponin Subunit
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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  • K230994 — Alinity i STAT High Sensitivity Troponin-I (May 4, 2023)
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