VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448— 510(k) K063243

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K063243 for VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448, Substantially Equivalent on 2007-12-14. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2006-10-26
Decision date: 2007-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, 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.