FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS— 510(k) K111874

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K111874 for FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS, Substantially Equivalent on 2012-02-16. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 2011-07-01
Decision date: 2012-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

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Adverse events under product code LFR

product code LFR

Death: 3
Malfunction: 1,634
Total: 1,637

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.