TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM— 510(k) K053020

Substantially Equivalent

Bayer Healthcare, LLC

FDA 510(k) clearance K053020 for TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM, Substantially Equivalent on 2005-12-30. Applicant: Bayer Healthcare, LLC.

Clearance details

Applicant: Bayer Healthcare, LLC
Product code: Code MMI
Advisory panel: Clinical Chemistry
Date received: 2005-10-26
Decision date: 2005-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, 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.