VIDAS TROPONIN I (TNI), MODEL 30 445— 510(k) K030950

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K030950 for VIDAS TROPONIN I (TNI), MODEL 30 445, Substantially Equivalent on 2003-06-16. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2003-03-26
Decision date: 2003-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, 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.