FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254— 510(k) K082482

Substantially Equivalent

Taidoc Technology Corporation

FDA 510(k) clearance K082482 for FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254, Substantially Equivalent on 2009-01-30. Applicant: Taidoc Technology Corporation.

Clearance details

Applicant: Taidoc Technology Corporation
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2008-08-28
Decision date: 2009-01-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Taipei County, TW

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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.