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
97–120 of 145
Cleared Sep 30, 1985
GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS
K853826
Catachem, Inc.
Chemistry · 17d
Cleared Sep 04, 1985
GLUCOSE SR LIQUID STABLE REAGENT SET
K853464
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Sep 28, 1984
PDA GLUCOSE
K843541
Abbott Laboratories
Chemistry · 21d
Cleared Aug 27, 1984
SYSTEMATE GLUCOSE 67216
K843150
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jul 20, 1984
GLUCOSE ASSAY KIT-HEXOKINASE
K842510
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared May 22, 1984
SIGMA PROCEDURE 16-UV
K841555
Sigma Chemical Co.
Chemistry · 36d
Cleared Oct 14, 1983
HEXOKINASE, GLUCOSE
K832872
Pointe Scientific, Inc.,
Chemistry · 50d
Cleared Jul 06, 1983
GLUCOSE HEXOKINASE DIAG. KIT
K831560
Sclavo, Inc.
Chemistry · 51d
Cleared Jul 08, 1982
ULTRACHEM E-GLU
K821868
Harleco Diagnostics
Chemistry · 13d
Cleared Jun 25, 1982
ULTRACHEM E-GLU #64976&65040
K821475
Emd Chemicals, Inc.
Chemistry · 38d
Cleared Jun 02, 1982
ULTRACHEM E-GLU, #64976 & 65040
K821461
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
ULTRACHEM E-GLU #64976 & 65040
K821470
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Sep 29, 1981
ULTRA CHEM E-GLU #64976 & 65040
K812595
Harleco
Chemistry · 18d
Cleared Sep 01, 1981
GLUCOSE-HK SYSTEM PACK TEST
K812303
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Jul 15, 1981
ESKAFLOW TEST FOR GLUCOSE
K811849
Smithkline Diagnostics, Inc.
Chemistry · 14d
Cleared Dec 10, 1980
HEXOKINASE, GLUCOSE
K802810
Beckman Instruments, Inc.
Chemistry · 33d
Cleared Oct 03, 1980
F/LS MCA APPLICATION SOFTWARE
K801456
Instrumentation Laboratory CO
Immunology · 101d
Cleared Sep 16, 1980
GLUCOSE REAGENT(UV-HEXOKINASE)
K801765
Reagents Applications, Inc.
Chemistry · 50d
Cleared May 23, 1980
DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI
K801051
Data Medical Associates, Inc.
Chemistry · 18d
Cleared May 23, 1980
DATA-ZYME GLUCOSE HEXOKINASE UV
K801052
Data Medical Associates, Inc.
Chemistry · 18d
Cleared Jan 11, 1980
GLUCOSE (HEXOKINASE) REAGENT SET
K792532
Macomb Chemical Co.
Chemistry · 35d
Cleared Sep 27, 1979
GLUCOSE HEXOKINASE COIL REAGENT SYSTEM
K791760
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Jun 15, 1979
GLUCOSE (HK) REAGENT
K790786
Gilford Diagnostics
Chemistry · 53d
Cleared Jan 26, 1979
GLUCOSE REAGENT SYSTEM
K782136
American Monitor Corp.
Chemistry · 30d