CFR · Class II · 21 CFR 862.1345

FDA Product Code CFR: Hexokinase, Glucose

Leading manufacturers include Em Diagnostic Systems, Inc., Abbott Laboratories and Instrumentation Laboratory CO.

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 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 Jun 02, 2003
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
K031135
Dade Behring, Inc.
Chemistry · 54d
Cleared May 07, 1998
GLU
K981185
Abbott Laboratories
Chemistry · 35d
Cleared Feb 13, 1996
ROCHE REAGENT FOR GLUCOSE
K953847
Roche Diagnostic Systems, Inc.
Chemistry · 181d
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 Jan 27, 1993
ROCHE COBAS FUTURA GLUCOSE
K922811
Roche Diagnostic Systems, Inc.
Chemistry · 231d
Cleared Nov 25, 1992
EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415
K924572
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Jul 30, 1991
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
K912808
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Oct 03, 1989
ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT
K894394
Abbott Laboratories
Chemistry · 78d
Cleared Sep 07, 1989
GLUCOSE-HK TEST (GLU-HK) ITEM #65415
K894483
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Jan 03, 1989
GLUCOSE-HK TEST (GLUC-HK) ITEM #65665
K884736
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Nov 10, 1988
EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95
K884021
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Aug 09, 1988
ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT
K882334
Abbott Laboratories
Chemistry · 64d
Cleared Nov 23, 1987
MODIFIED PARAMAX GLUCOSE REAGENT
K873936
Baxter Healthcare Corp
Chemistry · 59d

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 →