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
121–144 of 208
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 May 07, 1984
ION SELECTIVE ELECTRODE
K841076
Cooper Biomedical, Inc.
Chemistry · 56d
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 Jun 17, 1983
DEMAND ANALYZER SYSTEM
K831477
Worthington Diagnostic Systems
Chemistry · 39d
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
Cleared Jul 13, 1982
GEMSTAR SYSTEM
K821335
Electro-Nucleonics Laboratories, Inc.
Chemistry · 69d
Cleared May 14, 1982
8700 CLINICAL CHEM. ANALYZER
K820888
Boehringer Mannheim Corp.
Chemistry · 45d
Cleared Apr 01, 1982
DUPONT AUTOMATIC CLINICAL ANALYZER
K820687
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 21d
Cleared Feb 04, 1982
ELECTROLYTE ANALYZER ACCESSORY
K820118
Boehringer Mannheim Corp.
Chemistry · 17d
Cleared Dec 10, 1981
BECKMAN SYSTEM E4A
K813160
Beckman Instruments, Inc.
Chemistry · 24d
Cleared Jul 23, 1981
KODAK EKTACHEM 400 ANALYZER
K811919
Eastman Kodak Company
Chemistry · 21d
Cleared May 27, 1981
HITACHI 705 AUTOMATIC BLOOD CHEMISTRY
K811194
Boehringer Mannheim Corp.
Chemistry · 27d