AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION— 510(k) K103230

Substantially Equivalent

Bestgen Biotech Corp.

FDA 510(k) clearance K103230 for AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION, Substantially Equivalent on 2012-04-24. Applicant: Bestgen Biotech Corp..

Clearance details

Applicant: Bestgen Biotech Corp.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2010-11-01
Decision date: 2012-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
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.