GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System— 510(k) K142336

Substantially Equivalent

Arkray Factory, Inc.

FDA 510(k) clearance K142336 for GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System, Substantially Equivalent on 2014-09-17. Applicant: Arkray Factory, Inc..

Clearance details

Applicant: Arkray Factory, Inc.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2014-08-21
Decision date: 2014-09-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Koka-Shi, JP

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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.