JJE · Class I · 21 CFR 862.2160

FDA Product Code JJE: Analyzer, Chemistry (photometric, Discrete), For Clinical Use

Leading manufacturers include Eastman Kodak Company, Boehringer Mannheim Corp. and Abbott Laboratories.

208
Total
208
Cleared
71d
Avg days
1976
Since
208 devices
73–96 of 208
Cleared Feb 07, 1989
HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE
K885288
Eastman Kodak Company
Chemistry · 42d
Cleared Feb 07, 1989
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFT V5.0
K885289
Eastman Kodak Company
Chemistry · 42d
Cleared Feb 07, 1989
MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL.
K890183
Hichem Diagnostics
Chemistry · 20d
Cleared Feb 07, 1989
MODIFIED INTENDED USE OF CLEANING REAGENT KIT
K890184
Hichem Diagnostics
Chemistry · 20d
Cleared Dec 29, 1988
SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER
K884035
Sclavo, Inc.
Chemistry · 97d
Cleared Oct 31, 1988
SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER
K883539
Serono-Baker Diagnostics, Inc.
Chemistry · 76d
Cleared Oct 25, 1988
CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST
K883321
Heraeus Kulzer, Inc.
Chemistry · 81d
Cleared Sep 13, 1988
TECHNICON RA-100(TM) SYSTEM
K883209
Technicon Instruments Corp.
Chemistry · 46d
Cleared Sep 08, 1988
OLYMPUS REPLY CHEMISTRY ANALYZER
K882451
Olympus Corp.
Chemistry · 86d
Cleared Aug 30, 1988
DTR ANALYZER
K882913
Abbott Laboratories
Chemistry · 49d
Cleared Aug 30, 1988
VISTA INSTRUMENT
K882914
Abbott Laboratories
Chemistry · 49d
Cleared Jun 01, 1988
SYNCHRON CX(TM)5 CLINICAL ANALYZER
K881495
Beckman Instruments, Inc.
Chemistry · 54d
Cleared Jun 01, 1988
SYNCHRON CX(TM)4 CLINICAL ANALYZER
K881498
Beckman Instruments, Inc.
Chemistry · 54d
Cleared Feb 08, 1988
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.0
K874857
Eastman Kodak Company
Chemistry · 75d
Cleared Oct 19, 1987
GEMSTAR II SYSTEM
K873617
Electro-Nucleonics Laboratories, Inc.
Chemistry · 41d
Cleared Oct 19, 1987
CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER
K873749
Ciba Corning Diagnostics Corp.
Chemistry · 34d
Cleared Sep 08, 1987
MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER
K872302
Ciba Corning Diagnostics Corp.
Chemistry · 85d
Cleared Aug 13, 1987
EASY ST ANALYZER SYSTEM
K872813
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Jul 09, 1987
HITACHI 717 CHEMISTRY ANALYZER
K872494
Boehringer Mannheim Corp.
Chemistry · 15d
Cleared Jun 23, 1987
KODAK EKTACHEM 700XR ANALYZER
K872105
Eastman Kodak Company
Chemistry · 22d
Cleared Jun 17, 1987
KODAK EKTACHEM 700S ANALYZER
K872103
Eastman Kodak Company
Chemistry · 16d
Cleared Jun 17, 1987
KODAK EKTACHEM 700P ANALYZER
K872104
Eastman Kodak Company
Chemistry · 16d
Cleared Apr 01, 1987
CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY
K870833
Ciba Corning Diagnostics Corp.
Chemistry · 29d
Cleared Mar 12, 1987
AFFINITY(TM) SYSTEM
K865105
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 72d