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

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

73 devices
1–24 of 73
Cleared Sep 17, 2015
FreeStyle InsuLinx Blood Glucose Monotioring System
K152328
Abott Laboratories
Chemistry · 30d
Cleared Dec 17, 2014
ACCU-CHEK AVIVA EXPERT SYSTEM
K142089
Roche Diagnostics Corporation
Chemistry · 138d
Cleared Apr 28, 2014
EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM
K133537
Eps Bio Technology Corp.
Chemistry · 161d
Cleared Feb 28, 2014
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
K131727
Ceragem Medisys, Inc.
Chemistry · 261d
Cleared Oct 11, 2013
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
K131366
Roche Diagnostics Operations, Inc.
Chemistry · 151d
Cleared Apr 04, 2013
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
K122688
Nova Biomedical Corporation
Chemistry · 212d
Cleared Feb 14, 2013
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
K121433
Hmd Biomedical, Inc.
Chemistry · 276d
Cleared Dec 20, 2012
NOVA ONE BLOOD GLUCOSE MONITOR
K122435
Nova Biomedical Corporation
Chemistry · 132d
Cleared Nov 09, 2012
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K113314
Hmd Biomedical, Inc.
Chemistry · 366d
Cleared Sep 19, 2012
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
K121224
Taidoc Technology Corporation
Chemistry · 152d
Cleared Jul 27, 2012
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM
K113307
Hmd Biomedical, Inc.
Chemistry · 262d
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 May 18, 2012
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K121207
Eps Bio Technology Corp.
Chemistry · 28d
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 Mar 28, 2012
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
K110894
Bayer Healthcare
Chemistry · 364d
Cleared Mar 28, 2012
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
K113243
Eps Bio Technology Corp.
Chemistry · 147d
Cleared Mar 06, 2012
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
K111268
Bayer Healthcare
Chemistry · 307d
Cleared Feb 16, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
K111874
Abbott Laboratories
Chemistry · 230d
Cleared Dec 23, 2011
EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K112901
Eps Bio Technology Corp.
Chemistry · 81d
Cleared Sep 21, 2011
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
K101299
Roche Diagnostics
Chemistry · 499d
Cleared Sep 07, 2011
ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM
K110637
Cilag GmbH International
Chemistry · 187d
Cleared Sep 07, 2011
EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K112272
Eps Bio Technology Corp.
Chemistry · 30d

About Product Code LFR - Regulatory Context