Medical Device Manufacturer · US , Mchenry , IL

Lifescan, Inc. - FDA 510(k) Cleared Devices

42 submissions · 42 cleared · Since 1981
42
Total
42
Cleared
0
Denied
42 devices
26-42 of 42
Cleared Dec 16, 1997
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK
K972473 · CGA
Chemistry · 168d
Cleared May 12, 1997
SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM
K970556 · CGA
Chemistry · 88d
Cleared Apr 23, 1997
LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS
K971014 · JJX
Chemistry · 34d
Cleared Jul 03, 1995
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K950816 · CGA
Chemistry · 131d
Cleared Jun 01, 1995
ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM
K950727 · CGA
Chemistry · 105d
Cleared Mar 24, 1995
LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K942455 · CGA
Chemistry · 305d
Cleared Dec 03, 1992
ONE TOUCH TEST STRIPS
K923544 · CGA
Chemistry · 140d
Cleared Sep 15, 1992
ONE TOUCH IIB BLOOD GLUCOSE METER
K922888 · CGA
Chemistry · 91d
Cleared Nov 07, 1991
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
K913357 · CGA
Chemistry · 101d
Cleared Nov 08, 1989
ONE TOUCH II METER
K895911 · CGA
Chemistry · 29d
Cleared Sep 28, 1989
SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)
K894804 · JJX
Chemistry · 62d
Cleared Feb 25, 1987
MPX SYSTEM, GLUCOSE TEST SYSTEM
K864322 · CGA
Chemistry · 114d
Cleared Nov 05, 1982
GLUCOSCAN METER MODEL II
K822699 · CGA
Chemistry · 59d
Cleared Sep 30, 1982
GLUCOSCAN TEST STRIPS
K822697 · CGA
Chemistry · 23d
Cleared Sep 30, 1982
GLUCOSCAN CONTROLS
K822698 · JJX
Chemistry · 23d
Cleared Apr 29, 1981
GLUCOSCAN TEST STRIPS
K810993 · CGA
Chemistry · 16d
Cleared Apr 17, 1981
GILUCOCHEK REFLECTANCE METER
K810665 · JJQ
Chemistry · 37d
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