AMERLITE MAB FT4 ASSAY— 510(k) K920247

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K920247 for AMERLITE MAB FT4 ASSAY, Substantially Equivalent on 1992-03-02. Applicant: Eastman Kodak Company.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1992-01-21
Decision date: 1992-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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.