EUKARE— 510(k) K062892

Substantially Equivalent

Eumed Biotechnology Co., Ltd.

FDA 510(k) clearance K062892 for EUKARE, Substantially Equivalent on 2007-01-22. Applicant: Eumed Biotechnology Co., Ltd..

Clearance details

Applicant: Eumed Biotechnology Co., Ltd.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2006-09-26
Decision date: 2007-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

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.