FDA Product Code
FDA Product Code JJE — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2160
510(k) Clearances — 208 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K183375 | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode | Horiba, Ltd. | 2019-02-12 | Traditional | PDF ↗ |
| K133519 | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR | Carolina Liquid Chemistries Corp. | 2014-05-16 | Traditional | PDF ↗ |
| K130915 | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK | Jas Diagnostics, Inc. | 2014-05-15 | Traditional | PDF ↗ |
| K131554 | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT | Randox Laboratories, Ltd. | 2014-01-09 | Traditional | PDF ↗ |
| K130276 | DIMENSION EXL WITH LM SYSTEM | Siemens Healthcare Diagnostics, Inc. | 2013-03-22 | Traditional | PDF ↗ |
| K113253 | ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-05-17 | Traditional | PDF ↗ |
| K112999 | DIMENSION CLINICAL CHEMISTRY SYSTEM | Siemens Healthcare Diagnostics | 2011-11-22 | Special | PDF ↗ |
| K110035 | INDIKO | Thermofisher Scientific OY | 2011-06-28 | Traditional | PDF ↗ |
| K073370 | TC MATRIX CLINICAL CHEMISTRY ANALYZER | Teco Diagnostics | 2008-05-08 | Traditional | PDF ↗ |
| K063144 | VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM | Ortho-Clinical Diagnostics, Inc. | 2006-11-13 | Special | PDF ↗ |
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM | Dade Behring, Inc. | 2005-07-11 | Traditional | PDF ↗ |
| K042169 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER | Stanbio Laboratory | 2005-03-14 | Traditional | PDF ↗ |
| K040958 | PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 | Tokyo Boeki Medical System , Ltd. | 2005-02-15 | Traditional | PDF ↗ |
| K023764 | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 | Beckman Coulter, Inc. | 2003-01-28 | Traditional | PDF ↗ |
| K010500 | AUTOMATED WORKCELL CONTROL SOFTWARE | Lab-Interlink, Inc. | 2001-08-01 | Traditional | PDF ↗ |
| K003721 | MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | 2000-12-18 | Special | PDF ↗ |
| K002982 | OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | 2000-10-25 | Special | PDF ↗ |
| K983345 | BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY | Bayer Corp. | 1998-12-07 | Traditional | PDF ↗ |
| K974779 | ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER | Abbott Laboratories | 1998-02-13 | Traditional | PDF ↗ |
| K974651 | ABBOTT AXSYM SYSTEM | Abbott Laboratories | 1998-02-12 | Traditional | PDF ↗ |
| K971761 | PERSONALLAB AUTOMATED MICROPLATE ANALYZER | Biochem Immunosystems (U.S.), Inc. | 1997-07-22 | Traditional | PDF ↗ |
| K970227 | IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER | Dpc Cirrus | 1997-04-08 | Traditional | PDF ↗ |
| K965240 | SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L | Beckman Instruments, Inc. | 1997-03-10 | Traditional | PDF ↗ |
| K961142 | STRATEC LIA II ANALYZER | Nichols Institute Diagnostics | 1997-02-18 | Traditional | PDF ↗ |
| K963539 | SIGMA DIAGNOSTICS WASH CONCENTRATE | Sigma Diagnostics, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K962231 | COBAS CORE IMMUNOCHEMISTRY SYSTEM | Roche Diagnostic Systems, Inc. | 1996-08-30 | Traditional | PDF ↗ |
| K962125 | TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | 1996-08-02 | Traditional | PDF ↗ |
| K961274 | OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | 1996-07-05 | Traditional | PDF ↗ |
| K962235 | VITROS SPECIALTY DILUENT | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-06-26 | Traditional | PDF ↗ |
| K961481 | ELECSYS 2010 ANALYZER | Boehringer Mannheim Corp. | 1996-06-14 | Traditional | PDF ↗ |
| K953239 | BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER | Boehringer Mannheim Corp. | 1995-09-25 | Traditional | PDF ↗ |
| K942922 | SELECTA 20/60 CHEMISTRY ANALYZER | Select Medical Systems, Inc. | 1995-07-19 | Traditional | PDF ↗ |
| K951189 | SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0 | Beckman Instruments, Inc. | 1995-06-13 | Traditional | PDF ↗ |
| K945566 | ABBOTT PROJECT I, SPECTRUM | Abbott Laboratories | 1995-06-09 | Traditional | PDF ↗ |
| K950915 | ABBOTT AXSYM II SYSTEM | Abbott Laboratories | 1995-05-16 | Traditional | PDF ↗ |
| K950958 | SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA) | Beckman Instruments, Inc. | 1995-05-08 | Traditional | PDF ↗ |
| K945271 | ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM | Bio-Chem Laboratory Systems, Inc. | 1995-04-20 | Traditional | PDF ↗ |
| K950353 | TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | Miles, Inc. | 1995-04-20 | Traditional | PDF ↗ |
| K945135 | MICROPLATE PROCESSOR 3000 | Organon Teknika Corp. | 1995-03-03 | Traditional | PDF ↗ |
| K943493 | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | Hamilton Co. | 1995-01-30 | Traditional | PDF ↗ |
| K946090 | KODAK EKTACCHEM 950IRC ANALYZER | Clinical Diagnostic Systems, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K944028 | PROCHEM CHEMISTRY ANALYZER | Prisma Systems | 1994-11-30 | Traditional | PDF ↗ |
| K944093 | DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM | E.I. Dupont DE Nemours & Co., Inc. | 1994-11-10 | Traditional | PDF ↗ |
| K942364 | HITACHI 914 ANALYZER | Boehringer Mannheim Corp. | 1994-10-04 | Traditional | PDF ↗ |
| K942443 | AURAFLEX SYSTEMS | Organon Teknika Corp. | 1994-08-26 | Traditional | PDF ↗ |
| K940289 | ABBOTT PRISM ANALYZER | Abbott Mfg., Inc. | 1994-07-18 | Traditional | PDF ↗ |
| K940810 | CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF | Ciba Corning Diagnostics Corp. | 1994-05-23 | Traditional | PDF ↗ |
| K933703 | SIGMA WASH CONCENTRATE SOLUTION | Sigma Chemical Co. | 1993-12-10 | Traditional | PDF ↗ |
| K933548 | ELS 1000 | Bio-Tek Instruments, Inc. | 1993-10-29 | Traditional | PDF ↗ |
| K931786 | ACE CLINICAL CHEMISTRY SYSTEM | Schiapparelli Biosystems, Inc. | 1993-09-21 | Traditional | PDF ↗ |
| K931744 | OLYMPUS REPLY GLUCOSE REAGENT | Olympus Corp. | 1993-08-31 | Traditional | PDF ↗ |
| K930489 | AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS | E.I. Dupont DE Nemours & Co., Inc. | 1993-05-12 | Traditional | PDF ↗ |
| K923579 | MINIVIDAS INSTRUMENT | Biomerieux Vitek, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K926060 | SYNCHRON CX5CE CLINICAL ANALYZER | Beckman Instruments, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K924084 | ATAC 6000 CHEMISTRY ANALYZER | Bio-Chem Laboratory Systems, Inc. | 1992-09-29 | Traditional | PDF ↗ |
| K923060 | IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY | Becton Dickinson Advanced Diagnostics | 1992-09-15 | Traditional | PDF ↗ |
| K922680 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT | E.I. Dupont DE Nemours & Co., Inc. | 1992-08-20 | Traditional | PDF ↗ |
| K922139 | VISTA IMMUNOASSAY SYSTEM -- MODIFICATION | Syva Co. | 1992-07-21 | Traditional | PDF ↗ |
| K922072 | KODAK EKTACHEM 250 ANALYER | Eastman Kodak Company | 1992-07-10 | Traditional | PDF ↗ |
| K921661 | BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER | Boehringer Mannheim Corp. | 1992-06-30 | Traditional | PDF ↗ |
| K922220 | OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER | Olympus Corp. | 1992-06-25 | Traditional | PDF ↗ |
| K920402 | ROCHE COBAS MIRA PLUS | Roche Diagnostic Systems, Inc. | 1992-04-29 | Traditional | PDF ↗ |
| K915366 | MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER | Ciba Corning Diagnostics Corp. | 1992-03-17 | Traditional | PDF ↗ |
| K915106 | DIMENSION AR CLINICAL CHEMISTRY SYSTEM | Dupont Medical Products | 1992-01-28 | Traditional | PDF ↗ |
| K912844 | KODAK EKTACHEM DTII SYSTEM | Eastman Kodak Company | 1991-09-04 | Traditional | PDF ↗ |
| K912024 | AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R) | Wako Chemicals USA, Inc. | 1991-07-19 | Traditional | PDF ↗ |
| K910185 | SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER | Beckman Instruments, Inc. | 1991-04-03 | Traditional | PDF ↗ |
| K904219 | SYNCHRON CX 7 CLINICAL ANALYZER | Beckman | 1990-10-22 | Traditional | PDF ↗ |
| K904220 | SYNCHRON CX4-CE | Beckman | 1990-10-15 | Traditional | PDF ↗ |
| K903071 | KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN | Eastman Kodak Company | 1990-09-27 | Traditional | PDF ↗ |
| K902689 | ATAC 6000 CHEMISTRY ANALYZER | Bio-Chem Laboratories | 1990-07-10 | Traditional | PDF ↗ |
| K902336 | CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE | Ciba Corning Diagnostics Corp. | 1990-06-18 | Traditional | PDF ↗ |
| K901003 | BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER | Boehringer Mannheim Corp. | 1990-04-16 | Traditional | PDF ↗ |
| K901346 | ES 300 IMMUNOASSAY SYSTEM | Boehringer Mannheim Corp. | 1990-04-16 | Traditional | PDF ↗ |
| K895423 | ACCESS CHEMISTRY ANALYZER | American Monitor Corp. | 1989-10-04 | Traditional | PDF ↗ |
| K894222 | TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL | Abbott Laboratories | 1989-09-28 | Traditional | PDF ↗ |
| K893137 | EXCEL (TM) CHEMISTRY ANALYZER | American Monitor Corp. | 1989-08-10 | Traditional | PDF ↗ |
| K893776 | ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER | Abbott Laboratories | 1989-08-03 | Traditional | PDF ↗ |
| K893547 | CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER | Heraeus Kulzer, Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K890927 | KODAK EKTACHEM 500/750 SERIES ANALYZER, SOFT V1.0 | Eastman Kodak Company | 1989-03-28 | Traditional | PDF ↗ |
| K890929 | KODAK EKTACHEM 750 SERIES ANALYZER | Eastman Kodak Company | 1989-03-28 | Traditional | PDF ↗ |
| K890928 | KODAK EKTACHEM 500 ANALYZER | Eastman Kodak Company | 1989-03-28 | Traditional | PDF ↗ |
| K884378 | DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER | Coulter Corp. | 1989-02-27 | Traditional | PDF ↗ |
| K885226 | TECHNICON AXON(TM) SYSTEM | Technicon Instruments Corp. | 1989-02-17 | Traditional | PDF ↗ |
| K890184 | MODIFIED INTENDED USE OF CLEANING REAGENT KIT | Hichem Diagnostics | 1989-02-07 | Traditional | PDF ↗ |
| K885289 | KODAK EKTACHEM 700 ANALYZER FAMILY, SOFT V5.0 | Eastman Kodak Company | 1989-02-07 | Traditional | PDF ↗ |
| K890183 | MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL. | Hichem Diagnostics | 1989-02-07 | Traditional | PDF ↗ |
| K885288 | HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE | Eastman Kodak Company | 1989-02-07 | Traditional | PDF ↗ |
| K884035 | SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER | Sclavo, Inc. | 1988-12-29 | Traditional | PDF ↗ |
| K883533 | ABC FP ANALYZER | Intl. Bioclinical, Inc. | 1988-12-15 | Traditional | PDF ↗ |
| K883539 | SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER | Serono-Baker Diagnostics, Inc. | 1988-10-31 | Traditional | PDF ↗ |
| K883321 | CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST | Heraeus Kulzer, Inc. | 1988-10-25 | Traditional | PDF ↗ |
| K883209 | TECHNICON RA-100(TM) SYSTEM | Technicon Instruments Corp. | 1988-09-13 | Traditional | PDF ↗ |
| K882451 | OLYMPUS REPLY CHEMISTRY ANALYZER | Olympus Corp. | 1988-09-08 | Traditional | PDF ↗ |
| K882914 | VISTA INSTRUMENT | Abbott Laboratories | 1988-08-30 | Traditional | PDF ↗ |
| K882913 | DTR ANALYZER | Abbott Laboratories | 1988-08-30 | Traditional | PDF ↗ |
| K882559 | PROFILE ONE OMNI | Modular Diagnostic Systems, Inc. | 1988-08-08 | Traditional | PDF ↗ |
| K882194 | GEMINII GAMMA COUNTER | Laboratory Technologies, Inc. | 1988-08-04 | Traditional | PDF ↗ |
| K882307 | D-CHEM | Photec Diagnostics, Inc. | 1988-08-02 | Traditional | PDF ↗ |
| K882450 | GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK. | Diamond Sensor Systems | 1988-07-28 | Traditional | PDF ↗ |
Product code JJE · Class I · Clinical Chemistry. Data: openFDA.