LFR · Class II · 21 CFR 862.1345

FDA Product Code LFR: Glucose Dehydrogenase, Glucose

Leading manufacturers include Roche Diagnostics Corp., Boehringer Mannheim Corp. and Eps Bio Technology Corp..

73
Total
73
Cleared
137d
Avg days
1977
Since
73 devices
25–48 of 73
Cleared Jul 06, 2011
FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
K092688
Taidoc Technology Corporation
Chemistry · 673d
Cleared May 23, 2011
EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017
K101037
Eps Bio Technology Corp.
Chemistry · 404d
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 May 20, 2004
CLINICAL LABORATORY ANALYZING SYSTEM
K041230
Hemocue, Inc.
Chemistry · 10d
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
Cleared May 05, 2000
CONNECT DATA MANAGEMENT SYSTEM
K994433
Abbott Diabetes Care, Inc.
Chemistry · 127d
Cleared Feb 23, 2000
ACCU-CHEK COMPLETE METER
K000364
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Jan 14, 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
K992684
Abbott Diabetes Care, Inc.
Chemistry · 157d
Cleared Dec 09, 1999
ACCU-CHEK SIMPLICITY SYSTEM
K993829
Roche Diagnostics Corp.
Chemistry · 27d
Cleared Feb 05, 1999
ACCU-CHEK HQ SYSTEM
K983047
Boehringer Mannheim Corp.
Chemistry · 157d
Cleared Sep 03, 1998
ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS
K982089
Boehringer Mannheim Corp.
Chemistry · 80d
Cleared Sep 02, 1998
ACCU-CHEK COMFORT CURVE TEST STRIP
K982002
Boehringer Mannheim Corp.
Chemistry · 86d