CFR · Class II · 21 CFR 862.1345

FDA Product Code CFR: Hexokinase, Glucose

Leading manufacturers include Em Diagnostic Systems, Inc., Harleco and Heraeus Kulzer, Inc..

145
Total
145
Cleared
91d
Avg days
1976
Since
145 devices
49–72 of 145
Cleared Jul 22, 1997
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K971754
Pointe Scientific, Inc.,
Chemistry · 71d
Cleared Jun 16, 1997
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
K971276
Bayer Corp.
Chemistry · 70d
Cleared Jun 16, 1997
SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
K971467
Carolina Liquid Chemistries Corp.
Chemistry · 55d
Cleared Feb 10, 1997
GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS
K964004
Bayer Corp.
Chemistry · 126d
Cleared Dec 26, 1996
STC AUTO-LYTE URINARY GLUCOSE ASSAY
K962435
OraSure Technologies, Inc.
Chemistry · 185d
Cleared Oct 25, 1996
GLUCOSE (HEXOKINASE) KIT
K953210
Randox Laboratories, Ltd.
Chemistry · 473d
Cleared Jun 21, 1996
GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60
K961282
Diagnostic Chemicals , Ltd.
Chemistry · 79d
Cleared Apr 04, 1996
HICHEM GLUCOSE/HK REAGENT KIT
K960084
Hi Chem, Inc.
Chemistry · 84d
Cleared Feb 13, 1996
ROCHE REAGENT FOR GLUCOSE
K953847
Roche Diagnostic Systems, Inc.
Chemistry · 181d
Cleared Oct 03, 1995
DMA GLUCOSE HEXOKINASE U.V. PROCEDURE
K952437
Data Medical Associates, Inc.
Chemistry · 131d
Cleared Jun 01, 1995
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION
K951058
Heraeus Kulzer, Inc.
Chemistry · 86d
Cleared May 08, 1995
GLUCOSE (HK) REAGENT (PROCEDURE NO.16)
K945908
Sigma Diagnostics, Inc.
Chemistry · 157d
Cleared Mar 15, 1995
OLYMPUS GLUCOSE REAGENT
K944406
Olympus America, Inc.
Chemistry · 188d
Cleared Dec 29, 1994
GLUCOSE QVET
K942963
Prisma Systems
Chemistry · 189d
Cleared Dec 07, 1993
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION
K934900
Heraeus Kulzer, Inc.
Chemistry · 55d
Cleared Oct 12, 1993
IL TEST GLUCOSE
K931402
Instrumentation Laboratory CO
Chemistry · 207d
Cleared Jul 22, 1993
GLUCOSE-HK TEST
K931890
Em Diagnostic Systems, Inc.
Chemistry · 98d
Cleared Jun 24, 1993
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER
K926361
Heraeus Kulzer, Inc.
Chemistry · 185d
Cleared Jan 27, 1993
ROCHE COBAS FUTURA GLUCOSE
K922811
Roche Diagnostic Systems, Inc.
Chemistry · 231d
Cleared Dec 03, 1992
OLYMPUS GLUCOSE REAGENT
K924601
Olympus Corp.
Chemistry · 83d
Cleared Nov 25, 1992
EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415
K924572
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Nov 02, 1992
KING DIAGNOSTICS GLUCOSE (HK) REAGENT
K923129
King Diagnostics, Inc.
Chemistry · 129d
Cleared Sep 23, 1992
ENCORE TEST STRIPS
K923018
Heraeus Kulzer, Inc.
Chemistry · 92d
Cleared Sep 15, 1992
MILES URINE GLUCOSE METHOD
K923040
Heraeus Kulzer, Inc.
Chemistry · 88d