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Lifescan Europe

FDA Regulatory Profile

Lifescan Europe has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 8, 2016 · NAI
Latest 510(k)
Feb 14, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances3Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 8, 2016Zug, SwitzerlandDevicesNo Action Indicated (NAI)3008382007
Feb 12, 2014Zug, SwitzerlandDevicesNo Action Indicated (NAI)3008382007

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K193475OneTouch Verio Reflect Blood Glucose Monitoring SystemFeb 14, 2020
K151611OneTouch Ultra Plus Flex Blood Glucose Monitoring SystemDec 14, 2015
K150214OneTouch Verio Flex Blood Glucose Monitoring SystemJul 31, 2015

FDA data resources