510(k) K053531— DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR

Substantially Equivalent

Dade Behring, Inc.

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 2005-12-19
Decision date: 2006-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

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.