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
145 devices
25–48 of 145
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 May 22, 1984
SIGMA PROCEDURE 16-UV
K841555
Sigma Chemical Co.
Chemistry · 36d
Cleared Sep 01, 1981
GLUCOSE-HK SYSTEM PACK TEST
K812303
Boehringer Mannheim Corp.
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 Jun 22, 1978
PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE
K780858
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 29d
Cleared Sep 02, 1977
MULTISTAT III GLUCOSE TEST
K771464
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Feb 23, 1977
GLUCOSE (HEXOKINASE) DELTA TEST ASSAY
K770262
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 12d
Cleared Aug 26, 1976
GLUCOSE REAGENT SYS, SIGMA PROCED. 115
K760247
Sigma Chemical Co.
Chemistry · 38d