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Lifescan Inc

FDA Regulatory Profile

Summary

Total Recalls
3 (1 Class I)
510(k) Clearances
42
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1074-2013Class IAll OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ StarterMarch 11, 2013
Z-1129-2013Class IILifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. February 25, 2013
Z-1130-2013Class IILifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. Testing of BloodFebruary 25, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K132618ONETOUCH REVEALDecember 16, 2013
K120558ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATIONFebruary 7, 2013
K093745ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEMFebruary 11, 2011
K082590SYMPHONY METER REMOTEDecember 17, 2008
K082513ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEMOctober 22, 2008
K081318ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAMJune 9, 2008
K073231ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEMApril 18, 2008
K072543ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEMOctober 5, 2007
K062195MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEMAugust 16, 2006
K061118ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEMMay 19, 2006
K053529ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEMJanuary 17, 2006
K043197ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEMMay 20, 2005
K031472ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPSAugust 5, 2003
K024194ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMSFebruary 7, 2003
K023832SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEMDecember 13, 2002
K023194SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEMOctober 24, 2002
K022922HARMONY INR MONITORING SYSTEMSeptember 30, 2002
K022724SURESTEP BLOOD GLUCOSE MONITORING SYSTEMSeptember 12, 2002
K021819ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEMAugust 23, 2002
K021943ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEMJune 28, 2002