BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K022580

Substantially Equivalent

Becton, Dickinson & CO

FDA 510(k) clearance K022580 for BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2002-10-09. Applicant: Becton, Dickinson & CO.

Clearance details

Applicant: Becton, Dickinson & CO
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2002-08-05
Decision date: 2002-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

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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.