ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K110637
Substantially EquivalentCilag 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. Device class: 2.
Clearance details
- Applicant
- Cilag GmbH International
- Product code
- Code LFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zug, CH
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More clearances from Cilag GmbH International
view allAdverse events under product code LFR
product code LFR- Death
- 3
- Malfunction
- 1,634
- Total
- 1,637
Source: openFDA MAUDE database, through . 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.