BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR— 510(k) K041478

Substantially Equivalent

Becton Dickinson

FDA 510(k) clearance K041478 for BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR, Substantially Equivalent on 2004-10-28. Applicant: Becton Dickinson.

Clearance details

Applicant: Becton Dickinson
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2004-06-03
Decision date: 2004-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

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.