Lifescan, Inc.
Lifescan, Inc. holds FDA 510(k) medical device clearances, first cleared 1981, most recent 2013, with 3 FDA device recalls on record.
Top product codes for Lifescan, Inc.
FDA recalls by Lifescan, Inc.
- Z-1074-2013 — All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch¿ Verio IQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch¿ Verio IQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
- Z-1129-2013 — LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
- Z-1130-2013 — LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Lifescan, Inc.
- K132618 — ONETOUCH REVEAL
- K120558 — ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
- K093745 — ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
- K082590 — SYMPHONY METER REMOTE
- K082513 — ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
- K081318 — ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
- K073231 — ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
- K072543 — ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
- K062195 — MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
- K061118 — ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
- K053529 — ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
- K043197 — ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
- K031472 — ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS
- K024194 — ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS
- K023832 — SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
- K023194 — SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
- K022922 — HARMONY INR MONITORING SYSTEM
- K022724 — SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
- K021819 — ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
- K021943 — ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM
- K001699 — RUBICON PROTHROMBIN TIME MONITORING SYSTEM
- K001441 — SATURN BLOOD GLUCOSE MONITORING TEST STRIP
- K984261 — SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
- K984527 — IN TOUCH DIABETES MANAGEMENT SOFTWARE
- K974451 — ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
- K972473 — ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK
- K970556 — SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM
- K971014 — LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS
- K950816 — ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
- K950727 — ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM
- K942455 — LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
- K923544 — ONE TOUCH TEST STRIPS
- K922888 — ONE TOUCH IIB BLOOD GLUCOSE METER
- K913357 — ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
- K895911 — ONE TOUCH II METER
- K894804 — SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)
- K864322 — MPX SYSTEM, GLUCOSE TEST SYSTEM
- K822699 — GLUCOSCAN METER MODEL II
- K822697 — GLUCOSCAN TEST STRIPS
- K822698 — GLUCOSCAN CONTROLS
- K810993 — GLUCOSCAN TEST STRIPS
- K810665 — GILUCOCHEK REFLECTANCE METER
Data sourced from openFDA. This site is unofficial and independent of the FDA.