GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K051285

Substantially Equivalent

Infopia Co, Ltd.

FDA 510(k) clearance K051285 for GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2005-08-02. Applicant: Infopia Co, Ltd..

Clearance details

Applicant: Infopia Co, Ltd.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2005-05-17
Decision date: 2005-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang Kvunggi, KR

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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.