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 Laboratories.

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 Feb 16, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
K111874
Abbott Laboratories
Chemistry · 230d
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 Nov 13, 2000
SOF-TACT DIABETES MANAGEMENT SYSTEM
K001993
Abbott Laboratories
Chemistry · 137d
Cleared Feb 23, 2000
ACCU-CHEK COMPLETE METER
K000364
Roche Diagnostics Corp.
Chemistry · 19d
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
Cleared Aug 28, 1998
ACCU-CHECK VOICEMATE
K982079
Boehringer Mannheim Corp.
Chemistry · 74d
Cleared May 22, 1998
ACCU-CHEK COMFORT CURVE TEST STRIPS
K980731
Boehringer Mannheim Corp.
Chemistry · 86d
Cleared Dec 15, 1997
ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS
K973662
Boehringer Mannheim Corp.
Chemistry · 81d
Cleared Oct 09, 1997
GLUCOTREND BASIC SYSTEM
K972876
Boehringer Mannheim Corp.
Chemistry · 66d
Cleared Feb 15, 1996
ACCU-CHEK ADVANTAGE TEST STRIPS
K954833
Boehringer Mannheim Corp.
Chemistry · 118d
Cleared Aug 24, 1995
ADVANTAGE TEST STRIPS
K951887
Boehringer Mannheim Corp.
Chemistry · 122d
Cleared Dec 18, 1987
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008
K874708
Em Diagnostic Systems, Inc.
Chemistry · 29d

About Product Code LFR - Regulatory Context