CFR · Class II · 21 CFR 862.1345

FDA Product Code CFR: Hexokinase, Glucose

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

145
Total
145
Cleared
91d
Avg days
1976
Since
145 devices
25–48 of 145
Cleared Sep 11, 2006
GLUCOSE HK NEW FORMULATION TEST SYSTEM
K062239
Roche Diagnostics Corp.
Chemistry · 40d
Cleared May 17, 2006
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
K061048
Roche Diagnostics Corp.
Chemistry · 30d
Cleared May 05, 2006
GLUCOSE
K060383
Abbott Laboratories
Chemistry · 80d
Cleared Feb 27, 2006
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
K060256
Beckman Coulter, Inc.
Chemistry · 26d
Cleared Dec 16, 2005
ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)
K052007
Horiba Abx
Chemistry · 144d
Cleared Oct 11, 2005
ADVIA IMS GLUCOSE ASSAY
K052163
Bayer Healthcare, LLC
Chemistry · 63d
Cleared Apr 27, 2005
DATAPRO CLINICAL CHELISTRY ANALYZER
K042767
Thermo Electron Corporation
Chemistry · 204d
Cleared Jun 30, 2004
RAICHEM GLUCOSE UV (LIQUID)
K041052
Hemagen Diagnostics, Inc.
Chemistry · 72d
Cleared Jun 02, 2003
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
K031135
Dade Behring, Inc.
Chemistry · 54d
Cleared Feb 24, 2003
WAKO L-TYPE GLUCOSE 2
K024281
Wako Chemicals USA, Inc.
Chemistry · 63d
Cleared Jan 17, 2003
GLUCOSE-SL-C ASSAY, MODEL 257-30
K023739
Diagnostic Chemicals , Ltd.
Chemistry · 71d
Cleared Jul 03, 2002
POLY-CHEM GLUCOSE
K020852
Polymedco, Inc.
Chemistry · 110d
Cleared Nov 20, 2001
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
K011963
Bayer Corp.
Chemistry · 151d
Cleared Oct 15, 2001
RAICHEM GLUCOSE UV REAGENT
K012668
Hemagen Diagnostics, Inc.
Chemistry · 63d
Cleared Jul 31, 2001
GLUCOSE (HEXOKINASE)
K011900
Jas Diagnostics, Inc.
Chemistry · 43d
Cleared Nov 20, 2000
MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K002199
Pointe Scientific, Inc.,
Chemistry · 123d
Cleared Aug 10, 2000
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
K001403
Sigma Diagnostics, Inc.
Chemistry · 99d
Cleared Feb 08, 2000
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
K000102
Teco Diagnostics
Chemistry · 26d
Cleared May 25, 1999
GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02
K990981
A.P. Total Care, Inc.
Chemistry · 63d
Cleared Feb 11, 1999
INFINITY GLUCOSE REAGENT
K984574
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Sep 03, 1998
N-ASSAY GLU-UL
K980883
Crestat Diagnostics, Inc.
Chemistry · 178d
Cleared May 07, 1998
GLU
K981185
Abbott Laboratories
Chemistry · 35d
Cleared Mar 10, 1998
GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K980026
Trace America, Inc.
Chemistry · 64d
Cleared Aug 01, 1997
GLUCOSE REAGENT
K970664
Derma Media Lab., Inc.
Chemistry · 161d