KODAK AMERLEX MAB FT3 ASSAY— 510(k) K922771

Name: FDA 510(k) clearance K922771
Creator: U.S. Food and Drug Administration
Published: 1992-10-14

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K922771 for KODAK AMERLEX MAB FT3 ASSAY, Substantially Equivalent on 1992-10-14. Applicant: Eastman Kodak Company. Device class: 2.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1992-06-09
Decision date: 1992-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.