CFR · Class II · 21 CFR 862.1345

FDA Product Code CFR: Hexokinase, Glucose

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

145
Total
145
Cleared
91d
Avg days
1976
Since
Growing category - 2 submissions in the last 2 years vs 1 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 Apr 17, 2014
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
K131189
Beckman Coulter, Inc.
Chemistry · 356d
Cleared May 15, 2012
ADVIA CHEMISTRY GLUH_3 REAGENTS
K120681
Siemens Healthcare Diagnostics, Inc.
Chemistry · 70d
Cleared Mar 23, 2012
BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER
K112377
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Chemistry · 219d
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 Sep 16, 2009
EASYRA GLU-H REAGENT, MODEL 10200
K092506
Medica Corp.
Chemistry · 30d
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 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
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 Oct 11, 2005
ADVIA IMS GLUCOSE ASSAY
K052163
Bayer Healthcare, LLC
Chemistry · 63d
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 Nov 20, 2001
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
K011963
Bayer Corp.
Chemistry · 151d

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 1 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 →