K864838

Substantially Equivalent

SIMULTRAC FREE T4[57CO]/TSH MAB[125I]

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: CEC
Advisory panel: Clinical Chemistry
Date received: 1986-12-09
Decision date: 1987-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, 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.