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
Cleared
May 16, 1995
ABBOTT AXSYM II SYSTEM
Abbott Laboratories
Toxicology
76d
Cleared
May 08, 1995
SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA)
Beckman Instruments, Inc.
Chemistry
82d
Cleared
Mar 03, 1995
MICROPLATE PROCESSOR 3000
Organon Teknika Corp.
Chemistry
134d
Cleared
Nov 10, 1994
DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM
E.I. Dupont DE Nemours & Co., Inc.
Chemistry
80d
Cleared
Oct 04, 1994
HITACHI 914 ANALYZER
Boehringer Mannheim Corp.
Chemistry
140d
Cleared
Aug 26, 1994
AURAFLEX SYSTEMS
Organon Teknika Corp.
Chemistry
95d
Cleared
May 23, 1994
CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF
Ciba Corning Diagnostics Corp.
Chemistry
90d
Cleared
Dec 10, 1993
SIGMA WASH CONCENTRATE SOLUTION
Sigma Chemical Co.
Chemistry
134d
Cleared
Oct 29, 1993
ELS 1000
Bio-Tek Instruments, Inc.
Chemistry
101d
Cleared
Aug 31, 1993
OLYMPUS REPLY GLUCOSE REAGENT
Olympus Corp.
Chemistry
147d
Cleared
May 12, 1993
AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry
103d
Cleared
Feb 12, 1993
MINIVIDAS INSTRUMENT
Biomerieux Vitek, Inc.
Chemistry
207d
Cleared
Feb 12, 1993
SYNCHRON CX5CE CLINICAL ANALYZER
Beckman Instruments, Inc.
Chemistry
73d
Cleared
Aug 20, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT
E.I. Dupont DE Nemours & Co., Inc.
Hematology
77d
Cleared
Jul 21, 1992
VISTA IMMUNOASSAY SYSTEM -- MODIFICATION
Syva Co.
Chemistry
96d
Cleared
Jul 10, 1992
KODAK EKTACHEM 250 ANALYER
Eastman Kodak Company
Chemistry
67d
Cleared
Jun 30, 1992
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER
Boehringer Mannheim Corp.
Chemistry
84d
Cleared
Jun 25, 1992
OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER
Olympus Corp.
Chemistry
44d
Cleared
Apr 29, 1992
ROCHE COBAS MIRA PLUS
Roche Diagnostic Systems, Inc.
Chemistry
89d
Cleared
Mar 17, 1992
MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER
Ciba Corning Diagnostics Corp.
Chemistry
111d
Cleared
Sep 04, 1991
KODAK EKTACHEM DTII SYSTEM
Eastman Kodak Company
Chemistry
70d
Cleared
Jul 19, 1991
AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)
Wako Chemicals USA, Inc.
Chemistry
77d
Cleared
Apr 03, 1991
SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER
Beckman Instruments, Inc.
Chemistry
78d
Cleared
Sep 27, 1990
KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN
Eastman Kodak Company
Chemistry
77d