GLUCOCARD® W onyx Blood Glucose Monitoring System— 510(k) K183306

Substantially Equivalent

Arkray Factory, Inc.

FDA 510(k) clearance K183306 for GLUCOCARD® W onyx Blood Glucose Monitoring System, Substantially Equivalent on 2019-04-10. Applicant: Arkray Factory, Inc..

Clearance details

Applicant: Arkray Factory, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2018-11-28
Decision date: 2019-04-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Kamigyo-Ku, JP

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.