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Lifescan, Inc.

FDA 510(k) & PMA Approved Devices — 42 products

Total Devices42
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K132618 ONETOUCH REVEALMRZ2013-12-16 View
510(k) K120558 ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATIONNBW2013-02-07 View
510(k) K093745 ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEMNBW2011-02-11 View
510(k) K082590 SYMPHONY METER REMOTELZG2008-12-17 View
510(k) K082513 ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEMNBW2008-10-22 View
510(k) K081318 ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAMNBW2008-06-09 View
510(k) K073231 ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEMNBW2008-04-18 View
510(k) K072543 ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEMNBW2007-10-05 View
510(k) K062195 MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEMNBW2006-08-16 View
510(k) K061118 ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEMNBW2006-05-19 View
510(k) K053529 ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEMNBW2006-01-17 View
510(k) K043197 ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEMCGA2005-05-20 View
510(k) K031472 ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPSCGA2003-08-05 View
510(k) K024194 ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMSNBW2003-02-07 View
510(k) K023832 SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEMNBW2002-12-13 View
510(k) K023194 SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEMCGA2002-10-24 View
510(k) K022922 HARMONY INR MONITORING SYSTEMGJS2002-09-30 View
510(k) K022724 SURESTEP BLOOD GLUCOSE MONITORING SYSTEMNBW2002-09-12 View
510(k) K021819 ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEMNBW2002-08-23 View
510(k) K021943 ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEMCGA2002-06-28 View
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