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 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 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 Jun 22, 1984
ABBOTT PROJECT I
K841916
Abbott Laboratories
Chemistry · 44d
Cleared May 22, 1984
AMRESCO E4A REAGENT SET
K840868
American Research Products Co.
Chemistry · 85d
Cleared May 22, 1984
KODAK EKTACHEM DT 60 ANALYZER
K841503
Eastman Kodak Company
Chemistry · 42d
Cleared May 16, 1984
UNIPAK 100 ANALYZER, 65156 & CHEMISTR
K840883
Emd Chemicals, Inc.
Chemistry · 79d
Cleared Mar 23, 1984
UNI-FAST ANALYZER SYSTEM
K840129
Sclavo, Inc.
Chemistry · 72d
Cleared Feb 27, 1984
DISCRETE CLINICAL ANALYZER
K834521
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 68d
Cleared Jan 17, 1984
KODAK EKTACHEM 700 ANALYZER
K833833
Eastman Kodak Company
Chemistry · 75d
Cleared Dec 22, 1983
EPOS CHEMISTRY ANALYZER 5060 & 6410
K833448
Emd Chemicals, Inc.
Chemistry · 78d
Cleared Sep 20, 1983
ACCLAIM
K832648
Electro-Nucleonics Laboratories, Inc.
Chemistry · 46d
Cleared Sep 12, 1983
TUBING KIT 446
K832584
Shaban Mfg. Co.
Chemistry · 41d
Cleared Jun 22, 1983
AUTO CAROUSE/WASH SOLUTION CONCENTRATE
K831518
Syva Co.
Chemistry · 41d
Cleared Apr 12, 1983
OLYMPUS HIGH SPEED ANALYZER
K830762
Olympus Corp.
Chemistry · 33d
Cleared Mar 07, 1983
PARAMAX ANALYTICAL SYS
K830318
American Dade
Chemistry · 35d
Cleared Feb 25, 1983
STRATUS FLUOROMETRIC ENZYME IMMUN0-
K830301
American Hospital Supply Corp.
Chemistry · 28d
Cleared Jan 12, 1983
VARIOUS-ANALYZER CUPS
K823762
Cordis Corp.
Chemistry · 29d
Cleared Sep 14, 1982
ENZYMUNE SYSTEM I
K822465
Icl Scientific
Chemistry · 29d