LFR · Class II · 21 CFR 862.1345

FDA Product Code LFR: Glucose Dehydrogenase, Glucose

Leading manufacturers include Roche Diagnostics Corp., Boehringer Mannheim Corp. and Abbott Diabetes Care, Inc..

73
Total
73
Cleared
137d
Avg days
1977
Since

FDA 510(k) Cleared Glucose Dehydrogenase, Glucose Devices (Product Code LFR)

73 devices
1–24 of 73
Cleared Apr 04, 2013
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
K122688
Nova Biomedical Corporation
Chemistry · 212d
Cleared Dec 20, 2012
NOVA ONE BLOOD GLUCOSE MONITOR
K122435
Nova Biomedical Corporation
Chemistry · 132d
Cleared Sep 19, 2012
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
K121224
Taidoc Technology Corporation
Chemistry · 152d
Cleared Jul 26, 2012
CONTOUR NEXT BLOOD GLUCOSE METER
K121190
Bayer Healthcare, LLC
Chemistry · 98d
Cleared May 22, 2012
TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
K120042
Taidoc Technology Corporation
Chemistry · 138d
Cleared Apr 12, 2012
U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM
K113768
Taidoc Technology Corporation
Chemistry · 113d
Cleared Mar 28, 2012
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
K110587
Bayer Healthcare, LLC
Chemistry · 393d
Cleared Feb 16, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
K111874
Abbott Laboratories
Chemistry · 230d
Cleared Sep 21, 2011
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
K101299
Roche Diagnostics
Chemistry · 499d
Cleared Jul 06, 2011
FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
K092688
Taidoc Technology Corporation
Chemistry · 673d
Cleared Apr 16, 2009
RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01
K083223
Abbott Diabetes Care, Inc.
Chemistry · 164d
Cleared Nov 01, 2007
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
K070984
Abbott Diabetes Care, Inc.
Chemistry · 209d
Cleared Sep 02, 2005
MODIFICATION TO ACCU-CHEK GO SYSTEM
K051592
Roche Diagnostics Corp.
Chemistry · 79d
Cleared May 02, 2005
ACCU-CHEK INTEGRA SYSTEM
K050872
Roche Diagnostics Corp.
Chemistry · 26d
Cleared Apr 27, 2005
ACCU-CHEK AVIVA SYSTEM
K043474
Roche Diagnostics Corp.
Chemistry · 132d
Cleared Apr 22, 2004
ACCU-CHEK GO SYSTEM
K040796
Roche Diagnostics Corp.
Chemistry · 24d
Cleared Jul 03, 2003
ACCU-CHEK COMPACT TEST STRIP
K031755
Roche Diagnostics Corp.
Chemistry · 27d
Cleared Oct 28, 2002
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING
K022941
Abbott Laboratories
Chemistry · 55d
Cleared Aug 16, 2002
PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
K021960
Abbott Laboratories
Chemistry · 63d
Cleared Apr 26, 2001
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS
K004010
Roche Diagnostics Corp.
Chemistry · 121d
Cleared Mar 19, 2001
ACCU-CHEK INFORM METER
K003846
Roche Diagnostics Corp.
Chemistry · 97d
Cleared Mar 07, 2001
ACCU-CHEK COMFORT CURVE TEST STRIP
K010362
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Dec 05, 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
K000582
Abbott Diabetes Care, Inc.
Chemistry · 287d
Cleared Nov 13, 2000
SOF-TACT DIABETES MANAGEMENT SYSTEM
K001993
Abbott Laboratories
Chemistry · 137d

About Product Code LFR - Regulatory Context