K073604

Substantially Equivalent

DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

Applicant: Dade Behring, Inc.
Product code: CEC
Advisory panel: Clinical Chemistry
Date received: 2007-12-21
Decision date: 2008-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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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.