FDA 510(k) Applications for Medical Device Product Code "GKL"
(Counter, Cell, Automated (Particle Counter))

FDA 510(k) Number Applicant Device Name Decision Date
K803218 ABBOTT DIAGNOSTICS CELL DYN 800 HEMATOLOGY ANALYZER 06/09/1981
K840170 ABBOTT DIAGNOSTICS CELL-DYN 100 WHOLE BLOOD PLATELET 03/02/1984
K845019 ABBOTT DIAGNOSTICS CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER 03/26/1985
K832038 ABBOTT DIAGNOSTICS CELL-DYN 300 HEMATOLOGY ANALYZER 07/18/1983
K831368 ABBOTT DIAGNOSTICS CELL-DYN 400 HEMOTOLOGY ANALYZER 07/18/1983
K832643 ABBOTT DIAGNOSTICS CELL-DYN 900 HEMATOLOGY ANALYZER 09/26/1983
K823344 ABBOTT DIAGNOSTICS HEMATOLOGY ANALYZER 12/28/1982
K152776 Advanced Instruments, Inc. Glocyte Automated Cell Counter System 05/27/2016
K910679 ALICIA DIAGNOSTICS, INC. GENESIS I AUTOMATED CELL COUNTER 05/07/1991
K844042 AMERICAN SCIENTIFIC PRODUCTS BLOOD DILUTION VIAL 10/23/1984
K850386 BAKER INSTRUCTIONS CORP. SYSTEM 8000 CELL COUNTER 05/02/1985
K870603 BAKER INSTRUCTIONS CORP. SYSTEM 9000 AUTOMATED CELL COUNTER 03/31/1987
K971998 BAYER CORP. ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM 08/29/1997
K954607 BAYER CORP. RETICULOCYTE METHOD 08/30/1996
K022331 BAYER DIAGNOSTICS CORP. ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD 09/11/2002
K051693 BAYER HEALTHCARE, LLC MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM 12/07/2005
K832420 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC FACS ANALYZER 09/01/1983
K872166 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT 09/30/1987
K885132 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC FACSMATE SAMPLE HANDLING DEVICE 12/28/1988
K760582 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC HA/3 HEMATOLOGY ANALYZER 11/11/1976
K760581 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC HA/5 HEMATOLOGY ANALYZER 11/09/1976
K770385 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC LATELET DETERMIN. KIT, CAT NO. 2521 04/08/1977
K840658 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC QBC CENTRIFUGAL HEMATOLOGY ANALYZ 04/17/1984
K830451 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC QBC CENTRIFUGAL HEMATOLOGY SYS 04/27/1983
K923121 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC QBC HEMACAN HEMATOLOGY SYSTEM 09/22/1992
K880636 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RETICCOUNT SOFTWARE 03/21/1988
K761289 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800) 03/28/1977
K871830 BEECHER MEDICAL DIAGNOSTIC INSTRUMENTATION NAPSAC(TM) 09/09/1987
K760765 CLAY ADAMS, DIV. BECTON DICKINSON & CO. WHOLE BLOOD PLATELET COUNTER -2510 12/30/1976
K873271 CONTRAVES MEDICAL INSTRUMENTS, INC. DIGICELL 300 SYSTEM 11/06/1987
K873252 CONTRAVES MEDICAL INSTRUMENTS, INC. DIGICELL 500 11/06/1987
K962988 COULTER CORP. COULTER GEN-S SYSTEM 10/30/1996
K952308 COULTER CORP. COULTER Z 1 10/06/1995
K991070 COULTER CORP. COULTER Z2 ANALYZER 05/11/1999
K842346 COULTER ELECTRONICS, INC. COULTER AUTOMATIC SAMPLE HANDLER 07/27/1984
K851736 COULTER ELECTRONICS, INC. COULTER CHANNELYZER 256 07/30/1985
K834568 COULTER ELECTRONICS, INC. COULTER COUNTER M2 02/10/1984
K843303 COULTER ELECTRONICS, INC. COULTER COUNTER MODEL M4 12/05/1984
K853429 COULTER ELECTRONICS, INC. COULTER COUNTER MODEL M5 10/10/1985
K792537 COULTER ELECTRONICS, INC. COULTER COUNTER MODEL S PLUS 01/29/1980
K861780 COULTER ELECTRONICS, INC. COULTER COUNTER MODEL S PLUS JUNIOR 08/06/1986
K863085 COULTER ELECTRONICS, INC. COULTER COUNTER MODEL T-540 09/04/1986
K854114 COULTER ELECTRONICS, INC. COULTER COUNTER MODEL T-660 11/05/1985
K863084 COULTER ELECTRONICS, INC. COULTER COUNTER MODEL T-890 09/04/1986
K843164 COULTER ELECTRONICS, INC. COULTER COUNTER MODEL ZM 11/13/1984
K792668 COULTER ELECTRONICS, INC. COULTER COUNTER-BLOOD CELL COUNTER 01/29/1980
K885332 COULTER ELECTRONICS, INC. COULTER FLOW RETICULOCYTE REAGENT 02/22/1989
K851943 COULTER ELECTRONICS, INC. COULTER VOLUME ADAPTER 08/30/1985
K771512 COULTER ELECTRONICS, INC. COUNTER MODEL S PLUS BLOOD CELL COUNTER 11/09/1977
K781628 COULTER ELECTRONICS, INC. HEMO-W SYSTEM 10/27/1978
K802208 COULTER ELECTRONICS, INC. LEUKOCYTE VOL. ANALYSIS APPARATUS 09/17/1980
K872145 CRYO CORP. CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000) 11/13/1987
K840649 DANAM ELECTRONICS DANAM ELEC. SA-1000 07/19/1984
K834372 DIAGNOSTIC TECHNOLOGY, INC. PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ 02/10/1984
K860586 DIAGNOSTIC TECHNOLOGY, INC. PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS 05/07/1986
K842140 DIAGNOSTIC TECHNOLOGY, INC. PICOSCAL BLOOD CELL COUNTER PS-4 08/16/1984
K860166 DIAGNOSTIC TECHNOLOGY, INC. PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 04/04/1986
K853036 DIAGNOSTIC TECHNOLOGY, INC. PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 11/05/1985
K821238 DYSMEX CC-700 SEVEN PARAMETER, AUTOMATED HEMAA 05/28/1982
K854678 FUTURE IMPEX CORP. ERMA PC-602 PC-603 BLOOD CELL COUNTER 02/24/1986
K854677 FUTURE IMPEX CORP. ERMA PC-604 BLOOD CELL COUNTER 02/24/1986
K873172 HAMILTON THORNE RESEARCH HAMILTON-THORN MOTILITY ANALYZER HTM-2000 11/06/1987
K920719 HAMILTON THORNE RESEARCH IVOS ANALYZER 06/29/1992
K071652 HEMOCUE AB HEMOCUE WBC SYSTEM 10/25/2007
K930685 HERAEUS KULZER, INC. TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) 06/22/1993
K771107 HYCEL, INC. COUNTER 700 & HC-700 HEMO 0 REF. 07/11/1977
K782102 HYCEL, INC. HYCEL COUNTER 211 01/03/1979
K782101 HYCEL, INC. HYCEL COUNTER 222 01/03/1979
K782100 HYCEL, INC. HYCEL COUNTER 333 01/03/1979
K771353 HYCEL, INC. PLATELET COUNTER & HEMATOCRIT ACCES. 08/10/1977
K862374 INSTRUMENTATION LABORATORY CO. CELLECT 8E AUTOMATED BLOOD CELL COUNTERS 09/04/1986
K874320 INSTRUMENTATION LABORATORY CO. CELLECT LABTRAK SOFTWARE 01/27/1988
K863290 INSTRUMENTATION LABORATORY CO. IL CELLECT 7 09/04/1986
K863291 INSTRUMENTATION LABORATORY CO. IL CELLECT 8 09/04/1986
K934539 INTL. REMOTE IMAGING SYSTEMS THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY 03/30/1994
K954006 INTL. REMOTE IMAGING SYSTEMS YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY 03/12/1996
K914256 INTL. REMOTE IMAGING SYSTEMS YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU 05/01/1992
K091539 IRIS DIAGNOSTICS IQ 200 URINE ANALIZER BODY FLUIDS MODULE 08/31/2010
K050235 IRIS INTERNATIONAL, INC. IQ 200 URINE ANALYZER BODY FLUIDS MODULE 03/23/2005
K771790 J.T. BAKER CHEMICAL CO. DETECTOTERGE "AZIDE FREE" 10/07/1977
K803128 J.T. BAKER CHEMICAL CO. SERIES 810 PLATELET ANALYZER 04/03/1981
K884471 KVM INSTRUMENTS, INC. KVM BLOOD CELL COUNTER 12/27/1988
K803071 LABEX, INC. PLA-MATE 07/24/1981
K812031 LABTRONIX CORP. LPC II 08/12/1981
K770034 MALLINCKRODT CRITICAL CARE COUNTER, BLOOD CELL & HEMATOCRIT 02/16/1977
K823886 MALLINCKRODT CRITICAL CARE PROFILE 750 BLOOD CELL COUNTER 03/01/1983
K800346 MED LAB SYSTEMS, INC. HEMOSAFE 04/16/1980
K841803 MED USA A1 SYSTEME 8201/2 02/25/1985
K881765 MOTION ANALYSIS CORP. CTS-3060 AUTOMATED SEMEN ANALYZER 02/15/1989
K884618 NOVA BIOMEDICAL CORP. NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS 01/24/1989
K781146 ORTHO INSTRUMENTS HEMAC LASER HEMATOLOGY SYSTEM 09/14/1978
K801545 ORTHO INSTRUMENTS ORTHO AUTOMATED CELL COUNTER 09/09/1980
K802094 ORTHO INSTRUMENTS ORTHO SPECTRUM 10/10/1980
K791867 ROYCO INSTRUMENTS ROYCO MODEL 921 CELL COUNTER 11/05/1979
K833971 SERAGEN DIAGNOSTICS, INC. QUICK-COUNT 01/30/1984
K841504 SERAGEN DIAGNOSTICS, INC. QUICK-COUNT PLUS 2 06/11/1984
K802636 STRECK LABORATORIES, INC. PLATELET COUNTING KIT 12/11/1980
K032677 SYSMEX AMERICA, INC. SYSMEX POCH-100I 02/11/2004
K790026 SYSMEX CORP. ANALYZER, MODEL CC-720 02/08/1979
K981761 SYSMEX CORP. SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER 08/14/1998
K981950 SYSMEX CORP. SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 11/03/1998
K964375 SYSMEX CORP. SYSMEX SE/RAM-1 03/13/1997
K001683 SYSMEX CORPORATION OF AMERICA SYSMEX R-500 08/21/2000
K821575 SYSMEX/TOA MEDICAL ELECTRONICS, INC. SYSMEX CC-800 07/02/1982
K771728 TECHNICON INSTRUMENTS CORP. AUTO. LEUCOCYTE DIFFER. ANALYZER D/90 11/07/1977
K770666 TECHNICON INSTRUMENTS CORP. HEMALOG 8/90 05/06/1977
K834026 TECHNICON INSTRUMENTS CORP. RDW PARAMETER FOR THE TECHNICON H6000 01/30/1984
K873103 TECHNICON INSTRUMENTS CORP. TECHNICON H*1 JR.(TM) SYSTEM 08/28/1987
K853030 TECHNICON INSTRUMENTS CORP. TECHNICON H*1 SYSTEM (HDW) 02/05/1986
K811978 TECHNICON INSTRUMENTS CORP. TECHNICON H6000 (90/HR) HEMATOLOGY SYS 08/12/1981
K801155 TECHNICON INSTRUMENTS CORP. TECHNICON H6000 HEMATOLOGY SYSTEM 06/09/1980
K832627 TECHNICON INSTRUMENTS CORP. TECHNICON H6000 SYSTEM 09/12/1983
K832890 TEXAS INTL. LABORATORIES, INC. HEMACOMP 7 OR HEMATIL 7 10/19/1983
K853722 TEXAS INTL. LABORATORIES, INC. PLT-4 PLATELET ANALYZER 01/17/1986
K780224 TOA MEDICAL ELECTRONICS USA, INC. MICROCELL COUNTER MODEL CC-108 05/19/1978
K780909 TOA MEDICAL ELECTRONICS USA, INC. SYSMEX AUTO. BLOOD CELL COUNTER, CC-120 06/28/1978
K830505 TOA MEDICAL ELECTRONICS USA, INC. SYSMEX CC-130 05/09/1983
K830506 TOA MEDICAL ELECTRONICS USA, INC. SYSMEX CC-150 05/09/1983
K830507 TOA MEDICAL ELECTRONICS USA, INC. SYSMEX CC-170 05/13/1983
K830508 TOA MEDICAL ELECTRONICS USA, INC. SYSMEX CC-180 05/09/1983
K850171 TOA MEDICAL ELECTRONICS USA, INC. SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS 05/13/1985
K911173 TOA MEDICAL ELECTRONICS USA, INC. SYSMEX F-310 07/26/1991
K911172 TOA MEDICAL ELECTRONICS USA, INC. SYSMEX F-610 07/26/1991
K910849 TOA MEDICAL ELECTRONICS USA, INC. SYSMEX F-810 07/26/1991
K822758 TOA MEDICAL ELECTRONICS USA, INC. SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY 10/18/1982
K780911 TOA MEDICAL ELECTRONICS USA, INC. SYSMEX PLATELET COUNTER, PL-110 06/28/1978
K894539 TOA MEDICAL ELECTRONICS USA, INC. SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER 09/26/1989
K912494 TOA MEDICAL ELECTRONICS USA, INC. SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER 09/10/1991
K780910 TOA MEDICAL ELECTRONICS USA, INC. SYSTEM AUTO. BLOOD CELL COUNTER CC-110 06/28/1978
K863332 TURPEN LABORATORY SYSTEMS, INC. ATAC 4300 HEMATOLOGY CELL COUNTER 09/29/1986
K781562 VICKERS AMERICA MEDICAL CORP. HEMACHECK 11/15/1978


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