FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K111890

Substantially Equivalent

Taidoc Technology Corporation

FDA 510(k) clearance K111890 for FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2012-02-06. Applicant: Taidoc Technology Corporation.

Clearance details

Applicant: Taidoc Technology Corporation
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2011-07-01
Decision date: 2012-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

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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.