510(k) K052503— TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM

Substantially Equivalent

Bayer Healthcare, LLC

Clearance details

Applicant: Bayer Healthcare, LLC
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2005-09-13
Decision date: 2005-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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.