Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

43 results for "Lifescan, Inc."
1–24 of 43
Search insights Median review: 80d Cleared: 100% Top manufacturer: Lifescan, Inc. Lead specialty: Chemistry
Cleared Jun 07, 2017
OneTouch Via On-Demand Insulin Delivery System
K163357 · OPP
Lifescan Europe, A Division of Cilag...
General Hospital · 189d
Cleared Dec 16, 2013
ONETOUCH REVEAL
K132618 · MRZ
Lifescan, Inc.
General Hospital · 117d
Cleared Feb 07, 2013
ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
K120558 · NBW
Lifescan, Inc.
Chemistry · 349d
Cleared Feb 11, 2011
ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
K093745 · NBW
Lifescan, Inc.
Chemistry · 434d
Cleared Dec 17, 2008
SYMPHONY METER REMOTE
K082590 · LZG
Lifescan, Inc.
General Hospital · 100d
Cleared Oct 22, 2008
ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
K082513 · NBW
Lifescan, Inc.
Chemistry · 50d
Cleared Jun 09, 2008
ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
K081318 · NBW
Lifescan, Inc.
Chemistry · 28d
Cleared Apr 18, 2008
ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
K073231 · NBW
Lifescan, Inc.
Chemistry · 155d
Cleared Oct 05, 2007
ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
K072543 · NBW
Lifescan, Inc.
Chemistry · 25d
Cleared Aug 16, 2006
MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K062195 · NBW
Lifescan, Inc.
Chemistry · 15d
Cleared May 19, 2006
ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
K061118 · NBW
Lifescan, Inc.
Chemistry · 28d
Cleared Jan 17, 2006
ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
K053529 · NBW
Lifescan, Inc.
Chemistry · 29d
Cleared May 20, 2005
ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K043197 · CGA
Lifescan, Inc.
Chemistry · 183d
Cleared Aug 05, 2003
ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS
K031472 · CGA
Lifescan, Inc.
Chemistry · 88d
Cleared Feb 07, 2003
ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS
K024194 · NBW
Lifescan, Inc.
Chemistry · 49d
Cleared Dec 13, 2002
SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K023832 · NBW
Lifescan, Inc.
Chemistry · 25d
Cleared Oct 24, 2002
SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
K023194 · CGA
Lifescan, Inc.
Chemistry · 29d
Cleared Sep 30, 2002
HARMONY INR MONITORING SYSTEM
K022922 · GJS
Lifescan, Inc.
Hematology · 26d
Cleared Sep 12, 2002
SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K022724 · NBW
Lifescan, Inc.
Chemistry · 27d
Cleared Aug 23, 2002
ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K021819 · NBW
Lifescan, Inc.
Chemistry · 80d
Cleared Jun 28, 2002
ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM
K021943 · CGA
Lifescan, Inc.
Chemistry · 31d
Cleared May 15, 2001
RUBICON PROTHROMBIN TIME MONITORING SYSTEM
K001699 · GJS
Lifescan, Inc.
Hematology · 347d
Cleared Dec 18, 2000
SATURN BLOOD GLUCOSE MONITORING TEST STRIP
K001441 · CGA
Lifescan, Inc.
Chemistry · 224d
Cleared May 21, 1999
SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K984261 · CGA
Lifescan, Inc.
Chemistry · 175d