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
Jul 1, 1988K882081SPECIFIC CHEMISTRY ANALYZER
The Rupp & Bowman Co.
JJE
Jun 1, 1988K881498SYNCHRON CX(TM)4 CLINICAL ANALYZER
Beckman Instruments, Inc.
JJE
Jun 1, 1988K881495SYNCHRON CX(TM)5 CLINICAL ANALYZER
Beckman Instruments, Inc.
JJE
Feb 8, 1988K874857KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.0
Eastman Kodak Company
JJE
Oct 23, 1987K873130WASH SOLUTION KIT
A-Kem, Inc.
JJE
Oct 19, 1987K873749CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER
Ciba Corning Diagnostics Corp.
JJE
Oct 19, 1987K873617GEMSTAR II SYSTEM
Electro-Nucleonics Laboratories, Inc.
JJE
Sep 8, 1987K872302MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER
Ciba Corning Diagnostics Corp.
JJE
Aug 28, 1987K864849ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER
Antek Instruments, Inc.
JJE
Aug 13, 1987K872813EASY ST ANALYZER SYSTEM
Em Diagnostic Systems, Inc.
JJE
Jul 9, 1987K872494HITACHI 717 CHEMISTRY ANALYZER
Boehringer Mannheim Corp.
JJE
Jun 23, 1987K872105KODAK EKTACHEM 700XR ANALYZER
Eastman Kodak Company
JJE
Jun 17, 1987K872104KODAK EKTACHEM 700P ANALYZER
Eastman Kodak Company
JJE
Jun 17, 1987K872103KODAK EKTACHEM 700S ANALYZER
Eastman Kodak Company
JJE
Apr 1, 1987K870836ATAC 1500 CHEMISTRY ANALYZER
Turpen Laboratory Systems, Inc.
JJE
Apr 1, 1987K870833CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY
Ciba Corning Diagnostics Corp.
JJE
Mar 12, 1987K865105AFFINITY(TM) SYSTEM
Bd Becton Dickinson Vacutainer Systems Preanalytic
JJE
Nov 5, 1986K863840METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM
E.I. Dupont DE Nemours & Co., Inc.
JJE
Oct 20, 1986K863531IQ IMMUNOCHEMISTRY SYSTEM
Bd Becton Dickinson Vacutainer Systems Preanalytic
JJE
Sep 8, 1986K862235CIBA CORNING MAGIC LITE ANALYZER
Ciba Corning Diagnostics Corp.
JJE
Aug 19, 1986K862818STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
American Dade
JJE
Apr 24, 1986K861055EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95
Em Diagnostic Systems, Inc.
JJE
Apr 17, 1986K860748HITACHI 736
Boehringer Mannheim Corp.
JJE
Apr 17, 1986K860647ES600 IMMUNOASSAY SYSTEM
Boehringer Mannheim Corp.
JJE
Feb 11, 1986K860021DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM
E.I. Dupont DE Nemours & Co., Inc.
JJE
Feb 6, 1986K854936EIA PROCESSOR
Abbott Laboratories
JJE
Jan 24, 1986K860080OLYMPUS AU 5000 CHEMISTRY ANALYZER SYSTEM
Olympus Corp.
JJE
Jan 22, 1986K855196CLEANING REAGENT KIT PRODUCT NO 88194
Hi Chem, Inc.
JJE
Dec 5, 1985K853621REPLACEMENT PUMP TUBING
Shaban Mfg. Co.
JJE
Nov 19, 1985K854243ES 22
Boehringer Mannheim Corp.
JJE
Nov 12, 1985K854138KODAKEKTACHEM DTR MODULE
Eastman Kodak Company
JJE
Oct 28, 1985K854025HITACHI 704
Boehringer Mannheim Corp.
JJE
Oct 1, 1985K853391MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000
Eiken Chemical Co., Inc.
JJE
Sep 25, 1985K853699EASY ANALYZER & EASY-TEST REAGENT
Diagnostic Systems
JJE
Sep 16, 1985K852133REFLOTRON SYSTEM
Boehringer Mannheim Corp.
JJE
Aug 6, 1985K853003HI CHEM DIAGNOSTICS CLEANING NEUTRALIZER SOL#88193
Hi Chem, Inc.
JJE
Jun 25, 1985K852262ASSIST CLINICAL CHEMISTRY ANALYZER
Cooper Biomedical, Inc.
JJE
May 13, 1985K851638CLINALYZER MODEL VX-1000
Alpkem Corp.
JJE
Nov 27, 1984K844114ADD-1
Abbott Laboratories
JJE
Oct 17, 1984K843082ANALOX LM3 MICRO-STAT ANALYSER
Analox Instruments , Ltd.
JJE
Oct 11, 1984K843059ATAC 2000
Turpen Laboratory Systems, Inc.
JJE
Oct 5, 1984K843610PERSPECTIVE CHEMICAL ANALYZER
American Monitor Corp.
JJE
Oct 5, 1984K843283BOEHRINGER MANNHEIM DIAGNOSTICS ADAM
Boehringer Mannheim Corp.
JJE
Sep 4, 1984K842773LABSYSTEMS FP-901 CHEMISTRY ANALYZER
Labsystems, Inc.
JJE
Aug 16, 1984K842500DATA MGMT. SYSTEM
Gilford
JJE
Jun 22, 1984K841916ABBOTT PROJECT I
Abbott Laboratories
JJE
May 22, 1984K841503KODAK EKTACHEM DT 60 ANALYZER
Eastman Kodak Company
JJE
May 22, 1984K840868AMRESCO E4A REAGENT SET
American Research Products Co.
JJE
May 16, 1984K840883UNIPAK 100 ANALYZER, 65156 & CHEMISTR
Emd Chemicals, Inc.
JJE
May 7, 1984K841076ION SELECTIVE ELECTRODE
Cooper Biomedical, Inc.
JJE

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