GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System— 510(k) K142689

Substantially Equivalent

Apex BioTechnology Corp.

FDA 510(k) clearance K142689 for GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System, Substantially Equivalent on 2015-08-06. Applicant: Apex BioTechnology Corp..

Clearance details

Applicant: Apex BioTechnology Corp.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2014-09-22
Decision date: 2015-08-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsinchu, 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.