Elecsys Troponin T Gen 5— 510(k) K201441

Name: FDA 510(k) clearance K201441
Creator: U.S. Food and Drug Administration
Published: 2021-09-21

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K201441 for Elecsys Troponin T Gen 5, Substantially Equivalent on 2021-09-21. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code MMI
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2020-06-01
Decision date: 2021-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MMI

product code MMI

Injury: 172
Malfunction: 3,762
Total: 3,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.