AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K103116

Substantially Equivalent

Bestgen Biotech Corp.

FDA 510(k) clearance K103116 for AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2012-03-13. Applicant: Bestgen Biotech Corp..

Clearance details

Applicant: Bestgen Biotech Corp.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2010-10-21
Decision date: 2012-03-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Jung-He, Taipei County, 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.