ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS— 510(k) K091102

Name: FDA 510(k) clearance K091102
Creator: U.S. Food and Drug Administration
Published: 2009-10-23

Substantially Equivalent

Arkray Factory USA, Inc.

FDA 510(k) clearance K091102 for ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS, Substantially Equivalent on 2009-10-23. Applicant: Arkray Factory USA, Inc.. Device class: 2.

Clearance details

Applicant: Arkray Factory USA, Inc.
Product code: Code CGA
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2009-04-16
Decision date: 2009-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edina, MN, US

Download summary PDF View on FDA.gov ↗

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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.