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
25–48 of 208
Cleared Apr 03, 1991
SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER
K910185
Beckman Instruments, Inc.
Chemistry · 78d
Cleared Sep 27, 1990
KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN
K903071
Eastman Kodak Company
Chemistry · 77d
Cleared Apr 16, 1990
BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER
K901003
Boehringer Mannheim Corp.
Chemistry · 42d
Cleared Apr 16, 1990
ES 300 IMMUNOASSAY SYSTEM
K901346
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared Sep 28, 1989
TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL
K894222
Abbott Laboratories
Toxicology · 101d
Cleared Aug 03, 1989
ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER
K893776
Abbott Laboratories
Chemistry · 73d
Cleared Mar 28, 1989
KODAK EKTACHEM 500/750 SERIES ANALYZER, SOFT V1.0
K890927
Eastman Kodak Company
Chemistry · 32d
Cleared Mar 28, 1989
KODAK EKTACHEM 500 ANALYZER
K890928
Eastman Kodak Company
Chemistry · 32d
Cleared Mar 28, 1989
KODAK EKTACHEM 750 SERIES ANALYZER
K890929
Eastman Kodak Company
Chemistry · 32d
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 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 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 Mar 12, 1987
AFFINITY(TM) SYSTEM
K865105
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 72d
Cleared Nov 05, 1986
METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM
K863840
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 35d
Cleared Oct 20, 1986
IQ IMMUNOCHEMISTRY SYSTEM
K863531
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 40d