K955097

Substantially Equivalent

AMERLITE MAB FT4 ASSAY

Applicant: Kodak Clinical Diagnostics, Ltd.
Product code: CEC
Advisory panel: Clinical Chemistry
Date received: 1995-11-07
Decision date: 1995-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buckinghamshire, GB

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.