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)
12recalls in 12 months (564 all time)
494recalls that name a 510(k)
Top companies in JJE
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2019 | K183375 | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode Horiba, Ltd., JP | JJE |
| May 16, 2014 | K133519 | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR Carolina Liquid Chemistries Corp. | JJE |
| May 15, 2014 | K130915 | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK Jas Diagnostics, Inc. | JJE |
| Jan 9, 2014 | K131554 | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT Randox Laboratories, Ltd., GB | JJE |
| Mar 22, 2013 | K130276 | DIMENSION EXL WITH LM SYSTEM Siemens Healthcare Diagnostics, Inc. | JJE |
| May 17, 2012 | K113253 | ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | JJE |
| Nov 22, 2011 | K112999 | DIMENSION CLINICAL CHEMISTRY SYSTEM Siemens Healthcare Diagnostics | JJE |
| Jun 28, 2011 | K110035 | INDIKO Thermofisher Scientific OY, FI | JJE |
| May 8, 2008 | K073370 | TC MATRIX CLINICAL CHEMISTRY ANALYZER Teco Diagnostics | JJE |
| Nov 13, 2006 | K063144 | VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM Ortho-Clinical Diagnostics, Inc. | JJE |
| Jul 11, 2005 | K051087 | DIMENSION VISTA INTEGRATED SYSTEM Dade Behring, Inc. | JJE |
| Mar 14, 2005 | K042169 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER Stanbio Laboratory | JJE |
| Feb 15, 2005 | K040958 | PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 Tokyo Boeki Medical System , Ltd. | JJE |
| Jan 28, 2003 | K023764 | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 Beckman Coulter, Inc. | JJE |
| Aug 1, 2001 | K010500 | AUTOMATED WORKCELL CONTROL SOFTWARE Lab-Interlink, Inc. | JJE |
| Dec 18, 2000 | K003721 | MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc. | JJE |
| Oct 25, 2000 | K002982 | OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc. | JJE |
| Dec 7, 1998 | K983345 | BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY Bayer Corp. | JJE |
| Feb 13, 1998 | K974779 | ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER Abbott Laboratories | JJE |
| Feb 12, 1998 | K974651 | ABBOTT AXSYM SYSTEM Abbott Laboratories | JJE |
| Jul 22, 1997 | K971761 | PERSONALLAB AUTOMATED MICROPLATE ANALYZER Biochem Immunosystems (U.S.), Inc. | JJE |
| Apr 8, 1997 | K970227 | IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER Dpc Cirrus | JJE |
| Mar 10, 1997 | K965240 | SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L Beckman Instruments, Inc. | JJE |
| Feb 18, 1997 | K961142 | STRATEC LIA II ANALYZER Nichols Institute Diagnostics | JJE |
| Dec 16, 1996 | K963539 | SIGMA DIAGNOSTICS WASH CONCENTRATE Sigma Diagnostics, Inc. | JJE |
| Aug 30, 1996 | K962231 | COBAS CORE IMMUNOCHEMISTRY SYSTEM Roche Diagnostic Systems, Inc. | JJE |
| Aug 2, 1996 | K962125 | TECHNICON IMMUNO 1 SYSTEM Bayer Corp. | JJE |
| Jul 5, 1996 | K961274 | OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc. | JJE |
| Jun 26, 1996 | K962235 | VITROS SPECIALTY DILUENT Johnson & Johnson Clinical Diagnostics, Inc. | JJE |
| Jun 14, 1996 | K961481 | ELECSYS 2010 ANALYZER Boehringer Mannheim Corp. | JJE |
| Sep 25, 1995 | K953239 | BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER Boehringer Mannheim Corp. | JJE |
| Jul 19, 1995 | K942922 | SELECTA 20/60 CHEMISTRY ANALYZER Select Medical Systems, Inc. | JJE |
| Jun 13, 1995 | K951189 | SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0 Beckman Instruments, Inc. | JJE |
| Jun 9, 1995 | K945566 | ABBOTT PROJECT I, SPECTRUM Abbott Laboratories | JJE |
| May 16, 1995 | K950915 | ABBOTT AXSYM II SYSTEM Abbott Laboratories | JJE |
| May 8, 1995 | K950958 | SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA) Beckman Instruments, Inc. | JJE |
| Apr 20, 1995 | K950353 | TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM Miles, Inc. | JJE |
| Apr 20, 1995 | K945271 | ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM Bio-Chem Laboratory Systems, Inc. | JJE |
| Mar 3, 1995 | K945135 | MICROPLATE PROCESSOR 3000 Organon Teknika Corp. | JJE |
| Jan 30, 1995 | K943493 | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER Hamilton Co. | JJE |
| Jan 17, 1995 | K946090 | KODAK EKTACCHEM 950IRC ANALYZER Clinical Diagnostic Systems, Inc. | JJE |
| Nov 30, 1994 | K944028 | PROCHEM CHEMISTRY ANALYZER Prisma Systems | JJE |
| Nov 10, 1994 | K944093 | DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM E.I. Dupont DE Nemours & Co., Inc. | JJE |
| Oct 4, 1994 | K942364 | HITACHI 914 ANALYZER Boehringer Mannheim Corp. | JJE |
| Aug 26, 1994 | K942443 | AURAFLEX SYSTEMS Organon Teknika Corp. | JJE |
| Jul 18, 1994 | K940289 | ABBOTT PRISM ANALYZER Abbott Mfg., Inc. | JJE |
| May 23, 1994 | K940810 | CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF Ciba Corning Diagnostics Corp. | JJE |
| Dec 10, 1993 | K933703 | SIGMA WASH CONCENTRATE SOLUTION Sigma Chemical Co. | JJE |
| Oct 29, 1993 | K933548 | ELS 1000 Bio-Tek Instruments, Inc. | JJE |
| Sep 21, 1993 | K931786 | ACE CLINICAL CHEMISTRY SYSTEM Schiapparelli Biosystems, Inc. | JJE |
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