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."
25–43 of 43
Search insights Median review: 80d Cleared: 100% Top manufacturer: Lifescan, Inc. Lead specialty: Chemistry
Cleared Apr 29, 1999
IN TOUCH DIABETES MANAGEMENT SOFTWARE
K984527 · CGA
Lifescan, Inc.
Chemistry · 129d
Cleared Jan 26, 1998
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K974451 · CGA
Lifescan, Inc.
Chemistry · 62d
Cleared Dec 16, 1997
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK
K972473 · CGA
Lifescan, Inc.
Chemistry · 168d
Cleared May 12, 1997
SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM
K970556 · CGA
Lifescan, Inc.
Chemistry · 88d
Cleared Apr 23, 1997
LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS
K971014 · JJX
Lifescan, Inc.
Chemistry · 34d
Cleared Jul 03, 1995
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K950816 · CGA
Lifescan, Inc.
Chemistry · 131d
Cleared Jun 01, 1995
ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM
K950727 · CGA
Lifescan, Inc.
Chemistry · 105d
Cleared Mar 24, 1995
LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K942455 · CGA
Lifescan, Inc.
Chemistry · 305d
Cleared Dec 03, 1992
ONE TOUCH TEST STRIPS
K923544 · CGA
Lifescan, Inc.
Chemistry · 140d
Cleared Sep 15, 1992
ONE TOUCH IIB BLOOD GLUCOSE METER
K922888 · CGA
Lifescan, Inc.
Chemistry · 91d
Cleared Nov 07, 1991
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
K913357 · CGA
Lifescan, Inc.
Chemistry · 101d
Cleared Nov 08, 1989
ONE TOUCH II METER
K895911 · CGA
Lifescan, Inc.
Chemistry · 29d
Cleared Sep 28, 1989
SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)
K894804 · JJX
Lifescan, Inc.
Chemistry · 62d
Cleared Feb 25, 1987
MPX SYSTEM, GLUCOSE TEST SYSTEM
K864322 · CGA
Lifescan, Inc.
Chemistry · 114d
Cleared Nov 05, 1982
GLUCOSCAN METER MODEL II
K822699 · CGA
Lifescan, Inc.
Chemistry · 59d
Cleared Sep 30, 1982
GLUCOSCAN CONTROLS
K822698 · JJX
Lifescan, Inc.
Chemistry · 23d
Cleared Sep 30, 1982
GLUCOSCAN TEST STRIPS
K822697 · CGA
Lifescan, Inc.
Chemistry · 23d
Cleared Apr 29, 1981
GLUCOSCAN TEST STRIPS
K810993 · CGA
Lifescan, Inc.
Chemistry · 16d
Cleared Apr 17, 1981
GILUCOCHEK REFLECTANCE METER
K810665 · JJQ
Lifescan, Inc.
Chemistry · 37d