VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS— 510(k) K123016

Substantially Equivalent

Mico Biomed Co., Ltd.

FDA 510(k) clearance K123016 for VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS, Substantially Equivalent on 2013-06-18. Applicant: Mico Biomed Co., Ltd..

Clearance details

Applicant: Mico Biomed Co., Ltd.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2012-09-27
Decision date: 2013-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anseong, KR

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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.