FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K992684

Substantially Equivalent

Abbott Diabetes Care, Inc.

FDA 510(k) clearance K992684 for FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2000-01-14. Applicant: Abbott Diabetes Care, Inc..

Clearance details

Applicant: Abbott Diabetes Care, Inc.
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 1999-08-10
Decision date: 2000-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alameda, CA, US

Download summary PDF View on FDA.gov ↗

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.