BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)— 510(k) K113636

Name: FDA 510(k) clearance K113636
Creator: U.S. Food and Drug Administration
Published: 2013-03-08

Substantially Equivalent

Philosys Co., Ltd.

FDA 510(k) clearance K113636 for BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE), Substantially Equivalent on 2013-03-08. Applicant: Philosys Co., Ltd.. Device class: 2.

Clearance details

Applicant: Philosys Co., Ltd.
Product code: Code CGA
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2011-12-09
Decision date: 2013-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.