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 Jul 21, 1992
VISTA IMMUNOASSAY SYSTEM -- MODIFICATION
K922139
Syva Co.
Chemistry · 96d
Cleared Jul 10, 1992
KODAK EKTACHEM 250 ANALYER
K922072
Eastman Kodak Company
Chemistry · 67d
Cleared Jun 30, 1992
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER
K921661
Boehringer Mannheim Corp.
Chemistry · 84d
Cleared Jun 25, 1992
OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER
K922220
Olympus Corp.
Chemistry · 44d
Cleared Apr 29, 1992
ROCHE COBAS MIRA PLUS
K920402
Roche Diagnostic Systems, Inc.
Chemistry · 89d
Cleared Mar 17, 1992
MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER
K915366
Ciba Corning Diagnostics Corp.
Chemistry · 111d
Cleared Jan 28, 1992
DIMENSION AR CLINICAL CHEMISTRY SYSTEM
K915106
Dupont Medical Products
Chemistry · 76d
Cleared Sep 04, 1991
KODAK EKTACHEM DTII SYSTEM
K912844
Eastman Kodak Company
Chemistry · 70d
Cleared Jul 19, 1991
AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)
K912024
Wako Chemicals USA, Inc.
Chemistry · 77d
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 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