CFR · Class II · 21 CFR 862.1345

FDA Product Code CFR: Hexokinase, Glucose

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

145
Total
145
Cleared
91d
Avg days
1976
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 99d avg (recent)

FDA 510(k) Cleared Hexokinase, Glucose Devices (Product Code CFR)

145 devices
1–24 of 145
Cleared Feb 12, 2026
Glucose HK Gen.3
K253490
Roche Diagnostics
Chemistry · 111d
Cleared Oct 24, 2025
Glucose2
K252357
Abbott Ireland
Chemistry · 87d
Cleared Sep 16, 2022
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
K220134
Roche Diagnostics
Chemistry · 241d
Cleared Aug 16, 2019
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
K191899
Roche Diagnostics
Chemistry · 31d
Cleared Oct 19, 2017
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K170316
Abbott Laboratories
Chemistry · 260d
Cleared Sep 07, 2016
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
K153644
Elitechgroup
Chemistry · 261d
Cleared Jan 14, 2016
Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method
K151487
Diatron U.S., Inc.
Chemistry · 226d
Cleared Apr 17, 2014
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
K131189
Beckman Coulter, Inc.
Chemistry · 356d
Cleared Apr 23, 2013
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE
K123018
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry · 207d
Cleared May 15, 2012
ADVIA CHEMISTRY GLUH_3 REAGENTS
K120681
Siemens Healthcare Diagnostics, Inc.
Chemistry · 70d
Cleared May 10, 2012
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)
K120369
Hitachi Chemical Diagnostics, Inc.
Chemistry · 94d
Cleared Mar 23, 2012
BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER
K112377
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Chemistry · 219d
Cleared Mar 08, 2012
LIASYS 450
K113131
Ams
Chemistry · 136d
Cleared Dec 01, 2011
PRESTIGE 24I
K103531
Tokyo Boeki Medisys, Inc.
Chemistry · 365d
Cleared Nov 08, 2011
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
K103788
HORIBA ABX SAS
Chemistry · 316d
Cleared Mar 07, 2011
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
K101854
Siemens Healthcare Diagnostics
Chemistry · 249d
Cleared Dec 04, 2009
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
K092603
Roche Diagnostics
Chemistry · 101d
Cleared Oct 20, 2009
POLY-CHEM 90 GLUCOSE
K090703
Polymedco, Inc.
Chemistry · 217d
Cleared Sep 16, 2009
EASYRA GLU-H REAGENT, MODEL 10200
K092506
Medica Corp.
Chemistry · 30d
Cleared Sep 12, 2008
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
K081276
Horiba Abx
Chemistry · 130d
Cleared Jul 17, 2008
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
K080123
Wako Chemicals USA, Inc.
Chemistry · 182d
Cleared Jun 24, 2008
S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU
K072140
Alfa Wassermann Diagnostic Technologies, Inc.
Chemistry · 327d
Cleared Feb 01, 2008
BS-200 CHEMISTRY ANALYZER, MODE BS-200
K072018
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Chemistry · 193d
Cleared Jul 13, 2007
POINTE 360
K062118
Pointe Scientific, Inc.,
Chemistry · 353d

About Product Code CFR - Regulatory Context

510(k) Submission Activity

145 total 510(k) submissions under product code CFR since 1976, with 145 receiving FDA clearance (average review time: 91 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - CFR Product Code

FDA review times for CFR submissions have been consistent, averaging 99 days recently vs 91 days historically.

CFR devices are reviewed by the Chemistry panel. Browse all Chemistry devices →