| Glocyte Automated Cell Counter System (K152776) | Advanced Instruments, Inc. | 2016-05-27 |
| IQ 200 URINE ANALIZER BODY FLUIDS MODULE (K091539) | Iris Diagnostics | 2010-08-31 |
| HEMOCUE WBC SYSTEM (K071652) | Hemocue AB | 2007-10-25 |
| MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM (K051693) | Bayer Healthcare, LLC | 2005-12-07 |
| IQ 200 URINE ANALYZER BODY FLUIDS MODULE (K050235) | Iris International, Inc. | 2005-03-23 |
| SYSMEX POCH-100I (K032677) | Sysmex America, Inc. | 2004-02-11 |
| ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD (K022331) | Bayer Diagnostics Corp. | 2002-09-11 |
| SYSMEX R-500 (K001683) | Sysmex Corporation of America | 2000-08-21 |
| COULTER Z2 ANALYZER (K991070) | Coulter Corp. | 1999-05-11 |
| SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 (K981950) | Sysmex Corp. | 1998-11-03 |
| SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER (K981761) | Sysmex Corp. | 1998-08-14 |
| ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM (K971998) | Bayer Corp. | 1997-08-29 |
| SYSMEX SE/RAM-1 (K964375) | Sysmex Corp. | 1997-03-13 |
| COULTER GEN-S SYSTEM (K962988) | Coulter Corp. | 1996-10-30 |
| RETICULOCYTE METHOD (K954607) | Bayer Corp. | 1996-08-30 |
| YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY (K954006) | Intl. Remote Imaging Systems | 1996-03-12 |
| COULTER Z 1 (K952308) | Coulter Corp. | 1995-10-06 |
| THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY (K934539) | Intl. Remote Imaging Systems | 1994-03-30 |
| TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) (K930685) | Heraeus Kulzer, Inc. | 1993-06-22 |
| QBC HEMACAN HEMATOLOGY SYSTEM (K923121) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-09-22 |
| IVOS ANALYZER (K920719) | Hamilton Thorne Research | 1992-06-29 |
| YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU (K914256) | Intl. Remote Imaging Systems | 1992-05-01 |
| SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER (K912494) | Toa Medical Electronics USA, Inc. | 1991-09-10 |
| SYSMEX F-310 (K911173) | Toa Medical Electronics USA, Inc. | 1991-07-26 |
| SYSMEX F-610 (K911172) | Toa Medical Electronics USA, Inc. | 1991-07-26 |
| SYSMEX F-810 (K910849) | Toa Medical Electronics USA, Inc. | 1991-07-26 |
| GENESIS I AUTOMATED CELL COUNTER (K910679) | Alicia Diagnostics, Inc. | 1991-05-07 |
| SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER (K894539) | Toa Medical Electronics USA, Inc. | 1989-09-26 |
| COULTER FLOW RETICULOCYTE REAGENT (K885332) | Coulter Electronics, Inc. | 1989-02-22 |
| NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS (K884618) | Nova Biomedical Corp. | 1989-01-24 |
| FACSMATE SAMPLE HANDLING DEVICE (K885132) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-12-28 |
| KVM BLOOD CELL COUNTER (K884471) | Kvm Instruments, Inc. | 1988-12-27 |
| RETICCOUNT SOFTWARE (K880636) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-03-21 |
| CELLECT LABTRAK SOFTWARE (K874320) | Instrumentation Laboratory CO | 1988-01-27 |
| CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000) (K872145) | Cryo Corp. | 1987-11-13 |
| DIGICELL 300 SYSTEM (K873271) | Contraves Medical Instruments, Inc. | 1987-11-06 |
| HAMILTON-THORN MOTILITY ANALYZER HTM-2000 (K873172) | Hamilton Thorne Research | 1987-11-06 |
| DIGICELL 500 (K873252) | Contraves Medical Instruments, Inc. | 1987-11-06 |
| FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT (K872166) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-09-30 |
| NAPSAC(TM) (K871830) | Beecher Medical Diagnostic Instrumentation | 1987-09-09 |
| TECHNICON H*1 JR.(TM) SYSTEM (K873103) | Technicon Instruments Corp. | 1987-08-28 |
| SYSTEM 9000 AUTOMATED CELL COUNTER (K870603) | Baker Instructions Corp. | 1987-03-31 |
| ATAC 4300 HEMATOLOGY CELL COUNTER (K863332) | Turpen Laboratory Systems, Inc. | 1986-09-29 |
| CELLECT 8E AUTOMATED BLOOD CELL COUNTERS (K862374) | Instrumentation Laboratory CO | 1986-09-04 |
| IL CELLECT 7 (K863290) | Instrumentation Laboratory CO | 1986-09-04 |
| COULTER COUNTER MODEL T-540 (K863085) | Coulter Electronics, Inc. | 1986-09-04 |
| COULTER COUNTER MODEL T-890 (K863084) | Coulter Electronics, Inc. | 1986-09-04 |
| IL CELLECT 8 (K863291) | Instrumentation Laboratory CO | 1986-09-04 |
| COULTER COUNTER MODEL S PLUS JUNIOR (K861780) | Coulter Electronics, Inc. | 1986-08-06 |
| PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS (K860586) | Diagnostic Technology, Inc. | 1986-05-07 |
| PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 (K860166) | Diagnostic Technology, Inc. | 1986-04-04 |
| ERMA PC-602 PC-603 BLOOD CELL COUNTER (K854678) | Future Impex Corp. | 1986-02-24 |
| ERMA PC-604 BLOOD CELL COUNTER (K854677) | Future Impex Corp. | 1986-02-24 |
| TECHNICON H*1 SYSTEM (HDW) (K853030) | Technicon Instruments Corp. | 1986-02-05 |
| PLT-4 PLATELET ANALYZER (K853722) | Texas Intl. Laboratories, Inc. | 1986-01-17 |
| COULTER COUNTER MODEL T-660 (K854114) | Coulter Electronics, Inc. | 1985-11-05 |
| PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 (K853036) | Diagnostic Technology, Inc. | 1985-11-05 |
| COULTER COUNTER MODEL M5 (K853429) | Coulter Electronics, Inc. | 1985-10-10 |
| COULTER VOLUME ADAPTER (K851943) | Coulter Electronics, Inc. | 1985-08-30 |
| COULTER CHANNELYZER 256 (K851736) | Coulter Electronics, Inc. | 1985-07-30 |
| SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS (K850171) | Toa Medical Electronics USA, Inc. | 1985-05-13 |
| SYSTEM 8000 CELL COUNTER (K850386) | Baker Instructions Corp. | 1985-05-02 |
| CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER (K845019) | Abbott Diagnostics | 1985-03-26 |
| A1 SYSTEME 8201/2 (K841803) | Med USA | 1985-02-25 |
| COULTER COUNTER MODEL M4 (K843303) | Coulter Electronics, Inc. | 1984-12-05 |
| COULTER COUNTER MODEL ZM (K843164) | Coulter Electronics, Inc. | 1984-11-13 |
| BLOOD DILUTION VIAL (K844042) | American Scientific Products | 1984-10-23 |
| PICOSCAL BLOOD CELL COUNTER PS-4 (K842140) | Diagnostic Technology, Inc. | 1984-08-16 |
| COULTER AUTOMATIC SAMPLE HANDLER (K842346) | Coulter Electronics, Inc. | 1984-07-27 |
| DANAM ELEC. SA-1000 (K840649) | Danam Electronics | 1984-07-19 |
| QUICK-COUNT PLUS 2 (K841504) | Seragen Diagnostics, Inc. | 1984-06-11 |
| QBC CENTRIFUGAL HEMATOLOGY ANALYZ (K840658) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-04-17 |
| CELL-DYN 100 WHOLE BLOOD PLATELET (K840170) | Abbott Diagnostics | 1984-03-02 |
| PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ (K834372) | Diagnostic Technology, Inc. | 1984-02-10 |
| COULTER COUNTER M2 (K834568) | Coulter Electronics, Inc. | 1984-02-10 |
| QUICK-COUNT (K833971) | Seragen Diagnostics, Inc. | 1984-01-30 |
| RDW PARAMETER FOR THE TECHNICON H6000 (K834026) | Technicon Instruments Corp. | 1984-01-30 |
| HEMACOMP 7 OR HEMATIL 7 (K832890) | Texas Intl. Laboratories, Inc. | 1983-10-19 |
| CELL-DYN 900 HEMATOLOGY ANALYZER (K832643) | Abbott Diagnostics | 1983-09-26 |
| TECHNICON H6000 SYSTEM (K832627) | Technicon Instruments Corp. | 1983-09-12 |
| FACS ANALYZER (K832420) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-09-01 |
| CELL-DYN 400 HEMOTOLOGY ANALYZER (K831368) | Abbott Diagnostics | 1983-07-18 |
| CELL-DYN 300 HEMATOLOGY ANALYZER (K832038) | Abbott Diagnostics | 1983-07-18 |
| SYSMEX CC-170 (K830507) | Toa Medical Electronics USA, Inc. | 1983-05-13 |
| SYSMEX CC-130 (K830505) | Toa Medical Electronics USA, Inc. | 1983-05-09 |
| SYSMEX CC-150 (K830506) | Toa Medical Electronics USA, Inc. | 1983-05-09 |
| SYSMEX CC-180 (K830508) | Toa Medical Electronics USA, Inc. | 1983-05-09 |
| QBC CENTRIFUGAL HEMATOLOGY SYS (K830451) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-04-27 |
| PROFILE 750 BLOOD CELL COUNTER (K823886) | Mallinckrodt Critical Care | 1983-03-01 |
| HEMATOLOGY ANALYZER (K823344) | Abbott Diagnostics | 1982-12-28 |
| SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY (K822758) | Toa Medical Electronics USA, Inc. | 1982-10-18 |
| SYSMEX CC-800 (K821575) | Sysmex/Toa Medical Electronics, Inc. | 1982-07-02 |
| CC-700 SEVEN PARAMETER, AUTOMATED HEMAA (K821238) | Dysmex | 1982-05-28 |
| TECHNICON H6000 (90/HR) HEMATOLOGY SYS (K811978) | Technicon Instruments Corp. | 1981-08-12 |
| LPC II (K812031) | Labtronix Corp. | 1981-08-12 |
| PLA-MATE (K803071) | Labex, Inc. | 1981-07-24 |
| CELL DYN 800 HEMATOLOGY ANALYZER (K803218) | Abbott Diagnostics | 1981-06-09 |
| SERIES 810 PLATELET ANALYZER (K803128) | J.T. Baker Chemical Co. | 1981-04-03 |
| PLATELET COUNTING KIT (K802636) | Streck Laboratories, Inc. | 1980-12-11 |
| ORTHO SPECTRUM (K802094) | Ortho Instruments | 1980-10-10 |