K191595

Substantially Equivalent

ARCHITECT STAT High Sensitivity Troponin-I

Applicant: Abbott Laboratories Diagnostics Division
Product code: MMI
Advisory panel: Clinical Chemistry
Date received: 2019-06-17
Decision date: 2019-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, 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.