CFR · Class II · 21 CFR 862.1345

FDA Product Code CFR: Hexokinase, Glucose

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

145
Total
145
Cleared
91d
Avg days
1976
Since
145 devices
97–120 of 145
Cleared Feb 01, 1978
ULTRACHEM E-GLU, MANUAL DETERM.
K780065
Harleco
Chemistry · 20d
Cleared Sep 02, 1977
MULTISTAT III GLUCOSE TEST
K771464
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Aug 22, 1977
AUTOZYME IMMOBILIZED ENZYME COIL
K771384
Technicon Instruments Corp.
Chemistry · 26d
Cleared Aug 03, 1977
GLUCOSE REAGENT (HEXOHINASE)
K771311
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Jul 14, 1977
FLUCOSE U.V. TEST KIT
K770844
Mallinckrodt Critical Care
Chemistry · 66d
Cleared Jul 14, 1977
AUTO-ENZYMATIC GLUCOSE FOR ANALYZER
K770886
Harleco
Chemistry · 59d
Cleared Mar 01, 1977
AUTO-ENZYMATIC GLUCOSE
K770229
Harleco
Chemistry · 22d
Cleared Feb 23, 1977
GLUCOSE (HEXOKINASE) DELTA TEST ASSAY
K770262
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 12d
Cleared Jan 05, 1977
GLUCO-HEX TM REAGENT KIT
K761345
J.T. Baker Chemical Co.
Chemistry · 8d
Cleared Dec 29, 1976
AUTO-ENZYMATIC GLUCOSE
K761240
Harleco
Chemistry · 16d
Cleared Aug 26, 1976
REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER
K760055
Smithkline Diagnostics, Inc.
Chemistry · 71d
Cleared Aug 26, 1976
GLUCOSE REAGENT SYS, SIGMA PROCED. 115
K760247
Sigma Chemical Co.
Chemistry · 38d