ClearanceBrief
Panels › Clinical Chemistry › Product code JJE · Class 1

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Regulation 862.2160

0510(k)s in 12 months (208 all time)
10recalls in 12 months (564 all time)
494recalls that name a 510(k)
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Top companies in JJE

Company510(k)sRecalls
Beckman Coulter, Inc.1146
Ortho-Clinical Diagnostics, Inc.1130
Siemens Healthcare Diagnostics288
Abbott Laboratories1357
Roche Diagnostics Corp.042
Roche Diagnostics Operations, Inc.028
Eastman Kodak Company180
Boehringer Mannheim Corp.160
Abbott Gmbh & Co. KG014
Beckman Instruments, Inc.90
Decided510(k)Device and applicantCode
Apr 4, 1984K840501ACCULAB SUPPLIES CHEMICAL ANALYZERS
Precision Technology, Inc.
JJE
Mar 23, 1984K840129UNI-FAST ANALYZER SYSTEM
Sclavo, Inc.
JJE
Mar 23, 1984K840120ADVANTAGE
Gilford
JJE
Mar 9, 1984K834534APSARA ANALYZER
Datachem, Inc.
JJE
Feb 27, 1984K834521DISCRETE CLINICAL ANALYZER
E.I. Dupont DE Nemours & Co., Inc.
JJE
Jan 17, 1984K833833KODAK EKTACHEM 700 ANALYZER
Eastman Kodak Company
JJE
Jan 10, 1984K832115ATAC 3000
Turpen Laboratory Systems, Inc.
JJE
Dec 22, 1983K833448EPOS CHEMISTRY ANALYZER 5060 & 6410
Emd Chemicals, Inc.
JJE
Dec 8, 1983K833067IMPACT 400 #1447X2
Gilford
JJE
Nov 7, 1983K833116SPIRIT CHEMISTRY SYSTEM
Baker Instructions Corp.
JJE
Sep 20, 1983K832648ACCLAIM
Electro-Nucleonics Laboratories, Inc.
JJE
Sep 12, 1983K832584TUBING KIT 446
Shaban Mfg. Co.
JJE
Aug 24, 1983K831649THERMOMIXER S213-PHOTOANALYZER S263
Texas Intl. Laboratories, Inc.
JJE
Jun 22, 1983K831518AUTO CAROUSE/WASH SOLUTION CONCENTRATE
Syva Co.
JJE
Jun 17, 1983K831477DEMAND ANALYZER SYSTEM
Worthington Diagnostic Systems
JJE
Apr 12, 1983K830762OLYMPUS HIGH SPEED ANALYZER
Olympus Corp.
JJE
Apr 5, 1983K830212ELISA PLUS SYSTEM
William-Palmer Industries, Inc.
JJE
Mar 7, 1983K830318PARAMAX ANALYTICAL SYS
American Dade
JJE
Feb 25, 1983K830301STRATUS FLUOROMETRIC ENZYME IMMUN0-
American Hospital Supply Corp.
JJE
Feb 9, 1983K823386APSARA CLINICAL DIAG. & INFO. SYS
Datachem, Inc.
JJE
Jan 12, 1983K823762VARIOUS-ANALYZER CUPS
Cordis Corp.
JJE
Sep 14, 1982K822465ENZYMUNE SYSTEM I
Icl Scientific
JJE
Jul 13, 1982K821335GEMSTAR SYSTEM
Electro-Nucleonics Laboratories, Inc.
JJE
May 14, 1982K8208888700 CLINICAL CHEM. ANALYZER
Boehringer Mannheim Corp.
JJE
Apr 1, 1982K820687DUPONT AUTOMATIC CLINICAL ANALYZER
E.I. Dupont DE Nemours & Co., Inc.
JJE
Feb 4, 1982K820118ELECTROLYTE ANALYZER ACCESSORY
Boehringer Mannheim Corp.
JJE
Dec 10, 1981K813160BECKMAN SYSTEM E4A
Beckman Instruments, Inc.
JJE
Nov 24, 1981K813102POLI-MAK II
Pm America, Inc.
JJE
Jul 23, 1981K811919KODAK EKTACHEM 400 ANALYZER
Eastman Kodak Company
JJE
May 27, 1981K811194HITACHI 705 AUTOMATIC BLOOD CHEMISTRY
Boehringer Mannheim Corp.
JJE
Apr 8, 1981K810549THERMAL PRINTER PAPER
Nobel Scientific Industries, Inc.
JJE
Mar 17, 1981K810596CENTRIFI CHEM SYSTEM 400 ANALYZER
Union Carbide Corp.
JJE
Feb 2, 1981K810129CENTRIFICHEM SYSTEM 500
Union Carbide Corp.
JJE
Jan 16, 1981K803267AUTOMATED IMMUOCHEMISTRY SYSTEM
Beckman Instruments, Inc.
JJE
Jan 9, 1981K803135PARALLEL CHEMICAL ANALYZER
American Monitor Corp.
JJE
Dec 11, 1980K802835COMPU-CHEM II CHEMISTRY ANALYZER
Diagnostic Aids, Inc.
JJE
Nov 26, 1980K802609CHEMISTRY ANALYZER IMPACT 400
Gilford Instrument Laboratories, Inc.
JJE
Oct 31, 1980K802320COULTER DACOS SERUM CHEM. ANALYZER
Coulter Electronics, Inc.
JJE
Sep 26, 1980K801889MODEL 203S CLINICAL CHEMISTRY ANALYZER
Gilford Instrument Laboratories, Inc.
JJE
Apr 2, 1980K800572KDA MICRO CHEMICAL ANALYZER
American Monitor Corp.
JJE
Feb 13, 1980K800085SYSTEM 203 CHEMISTRY ANALYZER
Gilford Instrument Laboratories, Inc.
JJE
Jan 23, 1980K800053KODAK EKTACHEM FOUR CHEMISTRY ANALYZER
Eastman Kodak Company
JJE
Dec 27, 1979K792361SYSTEM 103 CHEMISTRY ANALYZER
Gilford Instrument Laboratories, Inc.
JJE
Aug 10, 1979K791297PRISMA
Lkb Instruments, Inc.
JJE
Aug 3, 1979K791296CHEMETRICS ANALYZER II
Chemetrics Corp.
JJE
Feb 22, 1979K790072ANALYZER, IMPACT 200
Gilford Instrument Laboratories, Inc.
JJE
Jan 10, 1979K782014ANALYZER ABA-200
Abbott Laboratories
JJE
Sep 27, 1978K781528COULTER ELECTROLYTE ANALYZER SYSTEM
Coulter Electronics, Inc.
JJE
Aug 14, 1978K781076CHEMISTRY ANALYZER
Johns Scientific, Inc.
JJE
May 3, 1978K780464LELECTIVE KINETIC SYSTEM-60
Hycel, Inc.
JJE

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