GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K102316

Substantially Equivalent

Broadmaster Biotech Corporation

FDA 510(k) clearance K102316 for GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2011-10-07. Applicant: Broadmaster Biotech Corporation.

Clearance details

Applicant: Broadmaster Biotech Corporation
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2010-08-16
Decision date: 2011-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhonghe City, TW

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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.