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
97–120 of 208
Cleared Nov 05, 1986
METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM
K863840
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 35d
Cleared Oct 20, 1986
IQ IMMUNOCHEMISTRY SYSTEM
K863531
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 40d
Cleared Sep 08, 1986
CIBA CORNING MAGIC LITE ANALYZER
K862235
Ciba Corning Diagnostics Corp.
Chemistry · 89d
Cleared Aug 19, 1986
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
K862818
American Dade
Chemistry · 26d
Cleared Apr 24, 1986
EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95
K861055
Em Diagnostic Systems, Inc.
Chemistry · 36d
Cleared Apr 17, 1986
ES600 IMMUNOASSAY SYSTEM
K860647
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Apr 17, 1986
HITACHI 736
K860748
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Feb 11, 1986
DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM
K860021
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 39d
Cleared Feb 06, 1986
EIA PROCESSOR
K854936
Abbott Laboratories
Chemistry · 58d
Cleared Jan 24, 1986
OLYMPUS AU 5000 CHEMISTRY ANALYZER SYSTEM
K860080
Olympus Corp.
Chemistry · 16d
Cleared Jan 22, 1986
CLEANING REAGENT KIT PRODUCT NO 88194
K855196
Hi Chem, Inc.
Chemistry · 27d
Cleared Dec 05, 1985
REPLACEMENT PUMP TUBING
K853621
Shaban Mfg. Co.
Chemistry · 98d
Cleared Nov 19, 1985
ES 22
K854243
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Nov 12, 1985
KODAKEKTACHEM DTR MODULE
K854138
Eastman Kodak Company
Chemistry · 33d
Cleared Oct 28, 1985
HITACHI 704
K854025
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Sep 16, 1985
REFLOTRON SYSTEM
K852133
Boehringer Mannheim Corp.
Chemistry · 123d
Cleared Aug 06, 1985
HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193
K853003
Hi Chem, Inc.
Chemistry · 21d
Cleared Jun 25, 1985
ASSIST CLINICAL CHEMISTRY ANALYZER
K852262
Cooper Biomedical, Inc.
Chemistry · 32d
Cleared May 13, 1985
CLINALYZER MODEL VX-1000
K851638
Alpkem Corp.
Chemistry · 24d
Cleared Nov 27, 1984
ADD-1
K844114
Abbott Laboratories
Chemistry · 35d
Cleared Oct 05, 1984
BOEHRINGER MANNHEIM DIAGNOSTICS ADAM
K843283
Boehringer Mannheim Corp.
Chemistry · 46d
Cleared Oct 05, 1984
PERSPECTIVE CHEMICAL ANALYZER
K843610
American Monitor Corp.
Chemistry · 22d
Cleared Sep 04, 1984
LABSYSTEMS FP-901 CHEMISTRY ANALYZER
K842773
Labsystems, Inc.
Chemistry · 50d
Cleared Jun 22, 1984
ABBOTT PROJECT I
K841916
Abbott Laboratories
Chemistry · 44d