ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K110637

Substantially Equivalent

Cilag GmbH International

FDA 510(k) clearance K110637 for ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2011-09-07. Applicant: Cilag GmbH International.

Clearance details

Applicant: Cilag GmbH International
Product code: Code LFR
Advisory panel: Clinical Chemistry
Date received: 2011-03-04
Decision date: 2011-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zug, CH

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.