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 Dec 16, 1996
SIGMA DIAGNOSTICS WASH CONCENTRATE
K963539
Sigma Diagnostics, Inc.
Chemistry · 103d
Cleared Aug 30, 1996
COBAS CORE IMMUNOCHEMISTRY SYSTEM
K962231
Roche Diagnostic Systems, Inc.
Chemistry · 81d
Cleared Aug 02, 1996
TECHNICON IMMUNO 1 SYSTEM
K962125
Bayer Corp.
Chemistry · 60d
Cleared Jul 05, 1996
OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER
K961274
Olympus America, Inc.
Chemistry · 94d
Cleared Jun 26, 1996
VITROS SPECIALTY DILUENT
K962235
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 15d
Cleared Jun 14, 1996
ELECSYS 2010 ANALYZER
K961481
Boehringer Mannheim Corp.
Chemistry · 57d
Cleared Sep 25, 1995
BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER
K953239
Boehringer Mannheim Corp.
Chemistry · 76d
Cleared Jul 19, 1995
SELECTA 20/60 CHEMISTRY ANALYZER
K942922
Select Medical Systems, Inc.
Chemistry · 393d
Cleared Jun 13, 1995
SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0
K951189
Beckman Instruments, Inc.
Chemistry · 89d
Cleared Jun 09, 1995
ABBOTT PROJECT I, SPECTRUM
K945566
Abbott Laboratories
Chemistry · 231d
Cleared May 16, 1995
ABBOTT AXSYM II SYSTEM
K950915
Abbott Laboratories
Toxicology · 76d
Cleared May 08, 1995
SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA)
K950958
Beckman Instruments, Inc.
Chemistry · 82d
Cleared Apr 20, 1995
ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM
K945271
Bio-Chem Laboratory Systems, Inc.
Chemistry · 184d
Cleared Apr 20, 1995
TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
K950353
Miles, Inc.
Chemistry · 80d
Cleared Mar 03, 1995
MICROPLATE PROCESSOR 3000
K945135
Organon Teknika Corp.
Chemistry · 134d
Cleared Jan 30, 1995
DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER
K943493
Hamilton Co.
Chemistry · 195d
Cleared Jan 17, 1995
KODAK EKTACCHEM 950IRC ANALYZER
K946090
Clinical Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Nov 30, 1994
PROCHEM CHEMISTRY ANALYZER
K944028
Prisma Systems
Chemistry · 105d
Cleared Nov 10, 1994
DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM
K944093
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 80d
Cleared Oct 04, 1994
HITACHI 914 ANALYZER
K942364
Boehringer Mannheim Corp.
Chemistry · 140d
Cleared Aug 26, 1994
AURAFLEX SYSTEMS
K942443
Organon Teknika Corp.
Chemistry · 95d
Cleared Jul 18, 1994
ABBOTT PRISM ANALYZER
K940289
Abbott Mfg., Inc.
Chemistry · 138d
Cleared May 23, 1994
CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF
K940810
Ciba Corning Diagnostics Corp.
Chemistry · 90d
Cleared Dec 10, 1993
SIGMA WASH CONCENTRATE SOLUTION
K933703
Sigma Chemical Co.
Chemistry · 134d