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
73 devices
25–48 of 73
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
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 Sep 06, 1995
GLUCOSE TEST ITEM NUMBER 97375/94
K951750
Emd Chemicals, Inc.
Chemistry · 142d
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
Cleared Apr 21, 1986
ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID
K860726
Trace Scientific , Ltd.
Chemistry · 54d
Cleared Feb 11, 1986
EMDS GLUCOSE TEST PACK ITEM 67656/95
K855080
Em Diagnostic Systems, Inc.
Chemistry · 54d
Cleared Jun 02, 1982
ULTRACHEM GLUC-DH, #65048
K821463
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
ULTRACHEM GLUC-DH, #65048
K821469
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Dec 31, 1981
ULTRACHEM GLUC-DH
K813427
Harleco
Chemistry · 24d
Cleared Nov 10, 1981
ULTRACHEM GLUC-DH SET, ITEM #65048
K813042
Harleco
Chemistry · 13d
Cleared May 27, 1981
ULTRACHEM GLUC-DH, ITEM NO. 65048
K811202
Harleco
Chemistry · 26d
Cleared Aug 10, 1979
GLUCOSE (GDH) REAGENT
K791213
Gilford Diagnostics
Chemistry · 39d
Cleared Dec 04, 1978
BLOOD SUGAR
K781783
Gilford Diagnostics
Chemistry · 46d