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
73–96 of 208
Cleared Jun 01, 1988
SYNCHRON CX(TM)4 CLINICAL ANALYZER
K881498
Beckman Instruments, Inc.
Chemistry · 54d
Cleared Feb 08, 1988
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.0
K874857
Eastman Kodak Company
Chemistry · 75d
Cleared Oct 19, 1987
GEMSTAR II SYSTEM
K873617
Electro-Nucleonics Laboratories, Inc.
Chemistry · 41d
Cleared Oct 19, 1987
CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER
K873749
Ciba Corning Diagnostics Corp.
Chemistry · 34d
Cleared Sep 08, 1987
MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER
K872302
Ciba Corning Diagnostics Corp.
Chemistry · 85d
Cleared Aug 13, 1987
EASY ST ANALYZER SYSTEM
K872813
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Jul 09, 1987
HITACHI 717 CHEMISTRY ANALYZER
K872494
Boehringer Mannheim Corp.
Chemistry · 15d
Cleared Jun 23, 1987
KODAK EKTACHEM 700XR ANALYZER
K872105
Eastman Kodak Company
Chemistry · 22d
Cleared Jun 17, 1987
KODAK EKTACHEM 700S ANALYZER
K872103
Eastman Kodak Company
Chemistry · 16d
Cleared Jun 17, 1987
KODAK EKTACHEM 700P ANALYZER
K872104
Eastman Kodak Company
Chemistry · 16d
Cleared Apr 01, 1987
CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY
K870833
Ciba Corning Diagnostics Corp.
Chemistry · 29d
Cleared Mar 12, 1987
AFFINITY(TM) SYSTEM
K865105
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 72d
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