ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS— 510(k) K082699

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K082699 for ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS, Substantially Equivalent on 2009-08-19. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2008-09-15
Decision date: 2009-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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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.