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 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 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 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 Jun 22, 1984
ABBOTT PROJECT I
K841916
Abbott Laboratories
Chemistry · 44d
Cleared May 22, 1984
KODAK EKTACHEM DT 60 ANALYZER
K841503
Eastman Kodak Company
Chemistry · 42d
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 Jun 22, 1983
AUTO CAROUSE/WASH SOLUTION CONCENTRATE
K831518
Syva Co.
Chemistry · 41d
Cleared Jan 12, 1983
VARIOUS-ANALYZER CUPS
K823762
Cordis Corp.
Chemistry · 29d
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
Cleared Jan 16, 1981
AUTOMATED IMMUOCHEMISTRY SYSTEM
K803267
Beckman Instruments, Inc.
Chemistry · 18d