Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Johnson & JohnsonLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record. See the Johnson & Johnson group view.
As of Nov 13, 2026, FDA's public records list LifeScan with 42 510(k) clearances and 3 device recalls. The most recent is a 510(k) clearance dated Dec 16, 2013: ONETOUCH REVEAL.
| Date | Record | Source |
|---|---|---|
| Dec 16, 2013 | ONETOUCH REVEALK132618 · MRZ | 510(k) clearances |
| Mar 11, 2013 | All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter.Class I · The Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HI | Device recalls |
| Feb 25, 2013 | LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.Class II · When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control solution the meter may di | Device recalls |
| Feb 25, 2013 | LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.Class II · When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control solution the meter may di | Device recalls |
| Feb 7, 2013 | ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATIONK120558 · NBW | 510(k) clearances |
| Feb 11, 2011 | ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEMK093745 · NBW | 510(k) clearances |
| Dec 17, 2008 | SYMPHONY METER REMOTEK082590 · LZG | 510(k) clearances |
| Oct 22, 2008 | ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEMK082513 · NBW | 510(k) clearances |
| Jun 9, 2008 | ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAMK081318 · NBW | 510(k) clearances |
| Apr 18, 2008 | ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEMK073231 · NBW | 510(k) clearances |
| Oct 5, 2007 | ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEMK072543 · NBW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
