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
145 devices
73–96 of 145
Cleared Jul 16, 1992
OLYMPUS GLUCOSE REAGENT
K922232
Olympus Corp.
Chemistry · 65d
Cleared Dec 18, 1991
TECHNICON CHEM 1 PLASMA GLUCOSE
K914794
Heraeus Kulzer, Inc.
Chemistry · 56d
Cleared Jul 30, 1991
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
K912808
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jul 18, 1991
KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST
K912251
King Diagnostics, Inc.
Chemistry · 58d
Cleared Mar 29, 1990
TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE
K901122
Technicon Instruments Corp.
Chemistry · 17d
Cleared Mar 09, 1990
COULTER GLUCOSE REAGENT
K897160
Coulter Electronics, Inc.
Chemistry · 71d
Cleared Nov 14, 1989
GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600
K896028
American Research Products Co.
Chemistry · 29d
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 Jun 20, 1989
AMRESCO PRODUCT NUMBER 7426
K891923
American Research Products Co.
Chemistry · 85d
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 Mar 15, 1988
GLUCOSE HEXOKINASE
K880236
Tech-Neal Scientific, Inc.
Chemistry · 55d
Cleared Mar 03, 1988
GLUCOSE (HEXOKINASE)
K874846
Tech-Co, Inc.
Chemistry · 100d
Cleared Nov 24, 1987
GLUCOSE-HK REAGENT
K873835
Intersect Systems, Inc.
Chemistry · 64d
Cleared Nov 23, 1987
MODIFIED PARAMAX GLUCOSE REAGENT
K873936
Baxter Healthcare Corp
Chemistry · 59d
Cleared Jun 05, 1987
MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919
K871976
Simmler, Inc.
Chemistry · 14d
Cleared Apr 29, 1987
ULTRA-VIOLET GLUCOSE REAGENT KIT
K871456
Biochemical Trade, Inc.
Chemistry · 16d
Cleared Sep 26, 1986
GLUCOSE HK PROCEDURE
K863259
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Apr 24, 1986
GLUCOSE (HEXOKINASE) REAGENT SET
K861311
Sterling Diagnostics, Inc.
Chemistry · 16d
Cleared Apr 07, 1986
ENZYMATIC GLUCOSE REAGENT (HEXOKINASE)
K860724
Trace Scientific , Ltd.
Chemistry · 40d
Cleared Mar 17, 1986
GLUCOSE HK-60 ASSAY KIT CAT. #201-39
K860625
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Jan 14, 1986
GLUCOSE (UV HEXOKIASE) REAGENT SET
K855153
Technostics Intl.
Chemistry · 19d