Dimension Vista High-Sensitivity Troponin I (TNIH) Assay— 510(k) K182225

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K182225 for Dimension Vista High-Sensitivity Troponin I (TNIH) Assay, Substantially Equivalent on 2019-03-04. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2018-08-16
Decision date: 2019-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Download summary PDF View on FDA.gov ↗

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.