K904539

Substantially Equivalent

FLAGEN TM FREE T4

Applicant: Cyberfluor, Inc.
Product code: CEC
Advisory panel: Clinical Chemistry
Date received: 1990-10-04
Decision date: 1990-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario M5t 1x4, CA

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.