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 Oct 29, 1993
ELS 1000
K933548
Bio-Tek Instruments, Inc.
Chemistry · 101d
Cleared Sep 21, 1993
ACE CLINICAL CHEMISTRY SYSTEM
K931786
Schiapparelli Biosystems, Inc.
Chemistry · 165d
Cleared Aug 31, 1993
OLYMPUS REPLY GLUCOSE REAGENT
K931744
Olympus Corp.
Chemistry · 147d
Cleared May 12, 1993
AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS
K930489
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 103d
Cleared Feb 12, 1993
MINIVIDAS INSTRUMENT
K923579
Biomerieux Vitek, Inc.
Chemistry · 207d
Cleared Feb 12, 1993
SYNCHRON CX5CE CLINICAL ANALYZER
K926060
Beckman Instruments, Inc.
Chemistry · 73d
Cleared Sep 29, 1992
ATAC 6000 CHEMISTRY ANALYZER
K924084
Bio-Chem Laboratory Systems, Inc.
Chemistry · 47d
Cleared Sep 15, 1992
IQ IMMUNOCHEMISTRY SISTEM
K923060
Becton Dickinson Advanced Diagnostics
Chemistry · 82d
Cleared Aug 20, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT
K922680
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 77d
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 Oct 22, 1990
SYNCHRON CX 7 CLINICAL ANALYZER
K904219
Beckman
Chemistry · 40d
Cleared Oct 15, 1990
SYNCHRON CX4-CE
K904220
Beckman
Chemistry · 33d
Cleared Sep 27, 1990
KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN
K903071
Eastman Kodak Company
Chemistry · 77d
Cleared Jul 10, 1990
ATAC 6000 CHEMISTRY ANALYZER
K902689
Bio-Chem Laboratories
Chemistry · 21d
Cleared Jun 18, 1990
CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE
K902336
Ciba Corning Diagnostics Corp.
Chemistry · 25d