| COULTER LH 750 HEMATOLOGY ANALYZER (K032342) | Beckman Coulter, Inc. | 2003-09-26 |
| IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER (K032039) | Sysmex America, Inc. | 2003-09-08 |
| ADVIA 60 HEMATOLOGY ANALYZER (K032524) | Bayer Healthcare, LLC | 2003-09-08 |
| COULTER LH 500 HEMATOLOGY ANALYZER (K032000) | Beckman Coulter, Inc. | 2003-08-13 |
| COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER (K032013) | Beckman Coulter, Inc. | 2003-07-24 |
| TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) (K030828) | Beckman Coulter, Inc. | 2003-05-21 |
| CELL-DYN 1800 SYSTEM (K030513) | Abbott Laboratories | 2003-05-12 |
| COULTER LH 750 BODY FLUIDS APPLICATION (K030606) | Beckman Coulter, Inc. | 2003-04-21 |
| COULTER ACT 5DIFF AUTOLOADER (AL) (K030291) | Beckman Coulter, Inc. | 2003-04-17 |
| MICROS 60 (K030799) | Abx Diagnostics | 2003-04-08 |
| CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A (K030408) | Beckman Coulter, Inc. | 2003-03-04 |
| MODIFICATION TO PENTRA 60 AND PENTRA 60C+ (K030144) | Abx Diagnostics | 2003-01-31 |
| PENTRA 80 (K024002) | Abx Diagnostics | 2003-01-03 |
| ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD (K022668) | Bayer Diagnostics Corp. | 2002-10-15 |
| IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ (K022528) | Iq Corp. | 2002-09-11 |
| PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 (K022200) | Abx Diagnostics | 2002-07-29 |
| MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 (K022161) | Beckman Coulter, Inc. | 2002-07-29 |
| SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I (K021241) | Sysmex Corporation of America | 2002-06-25 |
| HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY (K020496) | Sysmex Corporation of America | 2002-04-12 |
| CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE (K012934) | Abbott Laboratories | 2001-09-28 |
| ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION (K012904) | Bayer Diagnostics Corp. | 2001-09-21 |
| COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 (K011342) | Beckman Coulter, Inc. | 2001-07-09 |
| CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY (K010953) | Abbott Laboratories | 2001-06-06 |
| COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 (K010765) | Beckman Coulter, Inc. | 2001-04-13 |
| ADVIA 120 HEMATOLOGY (K003796) | Bayer Corp. | 2001-02-05 |
| ABX PENTRA 60C+ HEMATOLOGY ANALYZER (K003677) | Abx Diagnostics | 2000-12-26 |
| ABX MICROS CRP (K002646) | Abx Diagnostics | 2000-10-26 |
| STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER (K000611) | Bd Biosciences | 2000-05-18 |
| CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE (K000897) | Bd Biosciences | 2000-05-05 |
| COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES (K993356) | Coulter Corp. | 2000-04-20 |
| SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER (K992875) | Sysmex Corp. | 1999-11-09 |
| ABX PENTRA 60 HEMATOLOGY ANALYZER (K992511) | Abx Diagnostics | 1999-10-15 |
| MODIFICATION OF: CELL-DYN 1200 SYSTEM (K992444) | Abbott Laboratories | 1999-09-24 |
| QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (K992849) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1999-09-23 |
| ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER (K991839) | Abx Diagnostics | 1999-08-11 |
| CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (K991605) | Abbott Laboratories | 1999-07-09 |
| EXCELL 22 (K991539) | Mwi, Inc. | 1999-07-01 |
| CELL-DYN 1200 SYSTEM (K991142) | Abbott Laboratories | 1999-06-23 |
| DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 (K991402) | Dako Corp. | 1999-06-21 |
| MOUSE IGG1 NEGATIVE CONTROLS (K991454) | Dako Corp. | 1999-06-21 |
| RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS (K990327) | Coulter Corp. | 1999-04-26 |
| TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA (K990172) | Coulter Corp. | 1999-04-13 |
| COULTER AC T DIFF 2 ANALYZER (K990352) | Coulter Corp. | 1999-04-01 |
| VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER (K990311) | Abx Diagnostics | 1999-03-31 |
| CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 (K982167) | Coulter Corp. | 1998-11-09 |
| CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 (K982166) | Coulter Corp. | 1998-11-05 |
| MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700 (K983562) | Cdc Technologies, Inc. | 1998-11-03 |
| CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL (K982172) | Coulter Corp. | 1998-09-24 |
| BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K982802) | Bayer Corp. | 1998-09-22 |
| MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800 (K981568) | Cdc Technologies, Inc. | 1998-08-21 |
| DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 (K980635) | Dako Corp. | 1998-07-22 |
| STATUSFLOW (K982231) | R&D Systems, Inc. | 1998-07-20 |
| ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY (K981342) | Abbott Laboratories | 1998-06-29 |
| MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION (K980858) | Becton Dickinson Immunocytometry Systems | 1998-05-22 |
| ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS (K980614) | Abbott Laboratories | 1998-04-24 |
| MULTITEST CD3/CD8/CD45/CD4 (K974360) | Becton Dickinson Immunocytometry Systems | 1998-03-11 |
| FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET (K973483) | Becton Dickinson Immunocytometry Systems | 1998-02-17 |
| TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES (K971205) | Becton Dickinson Immunocytometry Systems | 1997-12-01 |
| TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES (K971110) | Becton Dickinson Immunocytometry Systems | 1997-11-25 |
| TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES (K970326) | Becton Dickinson Immunocytometry Systems | 1997-11-21 |
| TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES (K965053) | Becton Dickinson Immunocytometry Systems | 1997-11-21 |
| COULTER AC.T DIFF ANALYZER (K973634) | Coulter Corp. | 1997-10-29 |
| TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES (K970742) | Becton Dickinson Immunocytometry Systems | 1997-10-22 |
| ABBOTT CELL-DYN 3200 SYSTEM (K972354) | Abbott Laboratories | 1997-09-16 |
| SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER (K971736) | Sysmex Corp. | 1997-08-26 |
| TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS (K970836) | Becton Dickinson Immunocytometry Systems | 1997-08-26 |
| ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) (K971152) | Abbott Laboratories | 1997-08-12 |
| ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE (K951459) | Ortho Diagnostic Systems, Inc. | 1997-07-14 |
| MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE (K964974) | Dako Corp. | 1997-06-24 |
| CALTAG CAL-LYSE (K965232) | Caltag Laboratories, Inc. | 1997-05-14 |
| ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) (K951632) | Ortho Diagnostic Systems, Inc. | 1997-03-06 |
| COULTER AC.T SERIES ANALYZER (K964988) | Coulter Corp. | 1997-03-06 |
| SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX (K960072) | Biochem Immunosystems (U.S.), Inc. | 1997-03-06 |
| ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE (K964754) | Ortho Diagnostic Systems, Inc. | 1997-01-22 |
| TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5 (K963263) | Coulter Corp. | 1997-01-22 |
| CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (K964856) | Caltag Laboratories, Inc. | 1997-01-17 |
| CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL (K962305) | Coulter Corp. | 1997-01-06 |
| CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL (K962768) | Coulter Corp. | 1997-01-06 |
| CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1 (K964618) | Coulter Corp. | 1996-12-23 |
| MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS (K963963) | Becton Dickinson Immunocytometry Systems | 1996-12-12 |
| CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY (K963954) | Caltag Laboratories, Inc. | 1996-11-25 |
| VEGA HEMATOLOGY ANALYZER (K962633) | Abx, Inc. | 1996-11-04 |
| ABBOTT CELL-DYN 4000 SYSTEM (K961439) | Abbott Diagnostics | 1996-10-18 |
| CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) (K955715) | Abbott Laboratories | 1996-10-08 |
| RETICULOCYTE METHOD, RBC INDICES (K954594) | Bayer Corp. | 1996-08-23 |
| COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS (K961278) | Coulter Corp. | 1996-07-22 |
| MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE (K961701) | Dako Corp. | 1996-07-16 |
| R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) (K961610) | R&D Systems, Inc. | 1996-07-01 |
| MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE (K960531) | Dako Corp. | 1996-06-14 |
| MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE (K961435) | Dako Corp. | 1996-06-14 |
| FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS (K961623) | Becton Dickinson Monoclonal Center | 1996-06-07 |
| MEDICOUNT DEKA HEMATOLOGY ANALYZER (K942525) | Cea America Corp. | 1996-06-05 |
| CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) (K955673) | Abbott Laboratories | 1996-05-20 |
| QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) (K960827) | Becton Dickinson Diagnostic Instrument Systems | 1996-05-17 |
| MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE (K960887) | Dako Corp. | 1996-05-17 |
| ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) (K950568) | Ortho Diagnostic Systems, Inc. | 1996-05-13 |
| ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) (K950625) | Ortho Diagnostic Systems, Inc. | 1996-05-13 |
| ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) (K951100) | Ortho Diagnostic Systems, Inc. | 1996-05-13 |
| WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER (K953116) | Intl. Remote Imaging Systems | 1996-05-13 |
| ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) (K950482) | Ortho Diagnostic Systems, Inc. | 1996-05-10 |