Atlas FDA

ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k) clearance K110637 · decided 2011-09-07

Clearance details

K-number
K110637
Device name
ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Cilag GmbH International
Decision
Substantially Equivalent
Date received
2011-03-04
Decision date
2011-09-07
Days to decision
187 days
Clearance type
Traditional
Product code
LFR
Device class
2
Regulation number
862.1345
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Zug, CH
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ recall (Z-1359-2012)Lifescan Inc2012-04-02