K120448

Substantially Equivalent

MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL

Applicant: Apex BioTechnology Corp.
Product code: CGA
Advisory panel: Clinical Chemistry
Date received: 2012-02-14
Decision date: 2012-04-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu, TW

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.