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
49–72 of 208
Cleared Jun 18, 1990
CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE
K902336
Ciba Corning Diagnostics Corp.
Chemistry · 25d
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 Oct 04, 1989
ACCESS CHEMISTRY ANALYZER
K895423
American Monitor Corp.
Chemistry · 27d
Cleared Sep 28, 1989
TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL
K894222
Abbott Laboratories
Toxicology · 101d
Cleared Aug 10, 1989
EXCEL (TM) CHEMISTRY ANALYZER
K893137
American Monitor Corp.
Chemistry · 107d
Cleared Aug 03, 1989
CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER
K893547
Heraeus Kulzer, Inc.
Chemistry · 87d
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 27, 1989
DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER
K884378
Coulter Corp.
Chemistry · 132d
Cleared Feb 17, 1989
TECHNICON AXON(TM) SYSTEM
K885226
Technicon Instruments Corp.
Chemistry · 59d
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 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