K922713

Substantially Equivalent

KODAK AMERLITE MAB FT3 ASSAY

Applicant: Eastman Kodak Company
Product code: CEC
Advisory panel: Clinical Chemistry
Date received: 1992-06-05
Decision date: 1992-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, 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.