ELECSYS TROPONIN T STAT TEST— 510(k) K984105

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K984105 for ELECSYS TROPONIN T STAT TEST, Substantially Equivalent on 1998-12-08. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 1998-11-17
Decision date: 1998-12-08
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.