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
145–168 of 208
Cleared Apr 08, 1981
THERMAL PRINTER PAPER
K810549
Nobel Scientific Industries, Inc.
Chemistry · 37d
Cleared Mar 17, 1981
CENTRIFI CHEM SYSTEM 400 ANALYZER
K810596
Union Carbide Corp.
Chemistry · 11d
Cleared Feb 02, 1981
CENTRIFICHEM SYSTEM 500
K810129
Union Carbide Corp.
Chemistry · 14d
Cleared Jan 16, 1981
AUTOMATED IMMUOCHEMISTRY SYSTEM
K803267
Beckman Instruments, Inc.
Chemistry · 18d
Cleared Jan 09, 1981
PARALLEL CHEMICAL ANALYZER
K803135
American Monitor Corp.
Chemistry · 28d
Cleared Oct 31, 1980
COULTER DACOS SERUM CHEM. ANALYZER
K802320
Coulter Electronics, Inc.
Chemistry · 38d
Cleared Apr 02, 1980
KDA MICRO CHEMICAL ANALYZER
K800572
American Monitor Corp.
Chemistry · 19d
Cleared Jan 23, 1980
KODAK EKTACHEM FOUR CHEMISTRY ANALYZER
K800053
Eastman Kodak Company
Chemistry · 14d
Cleared Aug 10, 1979
PRISMA
K791297
Lkb Instruments, Inc.
Chemistry · 25d
Cleared Jan 10, 1979
ANALYZER ABA-200
K782014
Abbott Laboratories
Chemistry · 36d
Cleared Sep 27, 1978
COULTER ELECTROLYTE ANALYZER SYSTEM
K781528
Coulter Electronics, Inc.
Chemistry · 22d
Cleared May 03, 1978
LELECTIVE KINETIC SYSTEM-60
K780464
Hycel, Inc.
Chemistry · 42d
Cleared Mar 22, 1978
ANALYZER, 100, BICHROMATIC, ABBOTT
K780388
Syva Co.
Immunology · 12d
Cleared Oct 07, 1977
MODEL 2/2 ANALYZER
K771245
Eastman Kodak Company
Hematology · 88d
Cleared Aug 04, 1977
BICHROMATIC ANALYZER ABA-200
K771345
Abbott Laboratories
Chemistry · 15d
Cleared May 03, 1977
CHEMISTRY, COULTER
K770679
Coulter Electronics, Inc.
Chemistry · 22d