Counter, Cell, Automated (Particle Counter)
FDA product code GKL · 130 cleared devices
Class 2
Hematology
- Regulation
- 21 CFR 864.5200
- Review panel
- HE
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-11-09 – 2016-05-27
GKL
2016-05-27
GKL
2010-08-31
IQ 200 URINE ANALIZER BODY FLUIDS MODULE
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GKL
2007-10-25
HEMOCUE WBC SYSTEM
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GKL
2005-12-07
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
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GKL
2005-03-23
IQ 200 URINE ANALYZER BODY FLUIDS MODULE
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GKL
2004-02-11
SYSMEX POCH-100I
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GKL
2002-09-11
ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
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GKL
2000-08-21
SYSMEX R-500
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GKL
1999-05-11
COULTER Z2 ANALYZER
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GKL
1998-11-03
SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500
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GKL
1998-08-14
SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
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GKL
1997-08-29
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
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GKL
1997-03-13
SYSMEX SE/RAM-1
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GKL
1996-10-30
COULTER GEN-S SYSTEM
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GKL
1996-08-30
RETICULOCYTE METHOD
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GKL
1996-03-12
YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY
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GKL
1995-10-06
COULTER Z 1
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GKL
1994-03-30
THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY
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GKL
1993-06-22
TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)
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GKL
1992-09-22
QBC HEMACAN HEMATOLOGY SYSTEM
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GKL
1992-06-29
IVOS ANALYZER
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GKL
1992-05-01
YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU
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GKL
1991-09-10
SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER
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GKL
1991-07-26
SYSMEX F-310
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GKL
1991-07-26
SYSMEX F-610
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GKL
1991-07-26
SYSMEX F-810
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GKL
1991-05-07
GENESIS I AUTOMATED CELL COUNTER
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GKL
1989-09-26
SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER
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GKL
1989-02-22
COULTER FLOW RETICULOCYTE REAGENT
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GKL
1989-01-24
NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS
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GKL
1988-12-28
FACSMATE SAMPLE HANDLING DEVICE
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GKL
1988-12-27
KVM BLOOD CELL COUNTER
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GKL
1988-03-21
RETICCOUNT SOFTWARE
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GKL
1988-01-27
CELLECT LABTRAK SOFTWARE
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GKL
1987-11-13
CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)
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GKL
1987-11-06
DIGICELL 300 SYSTEM
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GKL
1987-11-06
DIGICELL 500
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GKL
1987-11-06
HAMILTON-THORN MOTILITY ANALYZER HTM-2000
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GKL
1987-09-30
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
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GKL
1987-09-09
NAPSAC(TM)
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GKL
1987-08-28
TECHNICON H*1 JR.(TM) SYSTEM
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GKL
1987-03-31
SYSTEM 9000 AUTOMATED CELL COUNTER
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GKL
1986-09-29
ATAC 4300 HEMATOLOGY CELL COUNTER
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GKL
1986-09-04
IL CELLECT 8
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GKL
1986-09-04
IL CELLECT 7
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GKL
1986-09-04
COULTER COUNTER MODEL T-540
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GKL
1986-09-04
COULTER COUNTER MODEL T-890
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GKL
1986-09-04
CELLECT 8E AUTOMATED BLOOD CELL COUNTERS
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GKL
1986-08-06
COULTER COUNTER MODEL S PLUS JUNIOR
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GKL
1986-05-07
PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS
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GKL
1986-04-04
PICOSCALE BLOOD CELL COUNTER, MODEL PS-5
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GKL
1986-02-24
ERMA PC-602 PC-603 BLOOD CELL COUNTER
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GKL
1986-02-24
ERMA PC-604 BLOOD CELL COUNTER
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GKL
1986-02-05
TECHNICON H*1 SYSTEM (HDW)
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GKL
1986-01-17
PLT-4 PLATELET ANALYZER
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GKL
1985-11-05
COULTER COUNTER MODEL T-660
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GKL
1985-11-05
PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1
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GKL
1985-10-10
COULTER COUNTER MODEL M5
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GKL
1985-08-30
COULTER VOLUME ADAPTER
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GKL
1985-07-30
COULTER CHANNELYZER 256
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GKL
1985-05-13
SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS
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GKL
1985-05-02
SYSTEM 8000 CELL COUNTER
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GKL
1985-03-26
CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER
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GKL
1985-02-25
A1 SYSTEME 8201/2
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GKL
1984-12-05
COULTER COUNTER MODEL M4
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GKL
1984-11-13
COULTER COUNTER MODEL ZM
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GKL
1984-10-23
BLOOD DILUTION VIAL
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GKL
1984-08-16
PICOSCAL BLOOD CELL COUNTER PS-4
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GKL
1984-07-27
COULTER AUTOMATIC SAMPLE HANDLER
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GKL
1984-07-19
DANAM ELEC. SA-1000
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GKL
1984-06-11
QUICK-COUNT PLUS 2
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GKL
1984-04-17
QBC CENTRIFUGAL HEMATOLOGY ANALYZ
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GKL
1984-03-02
CELL-DYN 100 WHOLE BLOOD PLATELET
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GKL
1984-02-10
COULTER COUNTER M2
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GKL
1984-02-10
PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ
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GKL
1984-01-30
RDW PARAMETER FOR THE TECHNICON H6000
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GKL
1984-01-30
QUICK-COUNT
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GKL
1983-10-19
HEMACOMP 7 OR HEMATIL 7
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GKL
1983-09-26
CELL-DYN 900 HEMATOLOGY ANALYZER
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GKL
1983-09-12
TECHNICON H6000 SYSTEM
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GKL
1983-09-01
FACS ANALYZER
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GKL
1983-07-18
CELL-DYN 300 HEMATOLOGY ANALYZER
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GKL
1983-07-18
CELL-DYN 400 HEMOTOLOGY ANALYZER
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GKL
1983-05-13
SYSMEX CC-170
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GKL
1983-05-09
SYSMEX CC-180
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GKL
1983-05-09
SYSMEX CC-150
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GKL
1983-05-09
SYSMEX CC-130
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GKL
1983-04-27
QBC CENTRIFUGAL HEMATOLOGY SYS
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GKL
1983-03-01
PROFILE 750 BLOOD CELL COUNTER
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GKL
1982-12-28
HEMATOLOGY ANALYZER
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GKL
1982-10-18
SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY
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GKL
1982-07-02
SYSMEX CC-800
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GKL
1982-05-28
CC-700 SEVEN PARAMETER, AUTOMATED HEMAA
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GKL
1981-08-12
LPC II
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GKL
1981-08-12
TECHNICON H6000 (90/HR) HEMATOLOGY SYS
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GKL
1981-07-24
PLA-MATE
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GKL
1981-06-09
CELL DYN 800 HEMATOLOGY ANALYZER
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GKL
1981-04-03
SERIES 810 PLATELET ANALYZER
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GKL
1980-12-11
PLATELET COUNTING KIT
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GKL
1980-10-10
ORTHO SPECTRUM
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