AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION— 510(k) K100437

Substantially Equivalent

Bestgen Biotech Corp.

FDA 510(k) clearance K100437 for AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION, Substantially Equivalent on 2012-01-12. Applicant: Bestgen Biotech Corp..

Clearance details

Applicant: Bestgen Biotech Corp.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2010-02-17
Decision date: 2012-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jhonghe City, Taipei County, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code NBW

product code NBW

Death: 18
Injury: 4,740
Malfunction: 42,679
Other: 6
Total: 47,443

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.