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