Product code GKL— Hematology
A1 SYSTEME 8201/2
- Classification name
- Counter, Cell, Automated (Particle Counter)
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Total cleared
- 130
- First cleared
- Most recent
Market context for product code GKL
FDA has cleared devices under product code GKL between 1976 and 2016, filed by 48 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2016
- 2010
- 2007
- 2005
- 2004
- 2002
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
Top applicants under product code GKL
Recent clearances under product code GKL
1–100 of 130- K152776 — Glocyte Automated Cell Counter System
- K091539 — IQ 200 URINE ANALIZER BODY FLUIDS MODULE
- K071652 — HEMOCUE WBC SYSTEM
- K051693 — MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
- K050235 — IQ 200 URINE ANALYZER BODY FLUIDS MODULE
- K032677 — SYSMEX POCH-100I
- K022331 — ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
- K001683 — SYSMEX R-500
- K991070 — COULTER Z2 ANALYZER
- K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500
- K981761 — SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER
- K971998 — ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
- K964375 — SYSMEX SE/RAM-1
- K962988 — COULTER GEN-S SYSTEM
- K954607 — RETICULOCYTE METHOD
- K954006 — YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY
- K952308 — COULTER Z 1
- K934539 — THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY
- K930685 — TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)
- K923121 — QBC HEMACAN HEMATOLOGY SYSTEM
- K920719 — IVOS ANALYZER
- K914256 — YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU
- K912494 — SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER
- K910849 — SYSMEX F-810
- K911172 — SYSMEX F-610
- K911173 — SYSMEX F-310
- K910679 — GENESIS I AUTOMATED CELL COUNTER
- K894539 — SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER
- K885332 — COULTER FLOW RETICULOCYTE REAGENT
- K884618 — NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS
- K885132 — FACSMATE SAMPLE HANDLING DEVICE
- K884471 — KVM BLOOD CELL COUNTER
- K880636 — RETICCOUNT SOFTWARE
- K874320 — CELLECT LABTRAK SOFTWARE
- K872145 — CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)
- K873172 — HAMILTON-THORN MOTILITY ANALYZER HTM-2000
- K873252 — DIGICELL 500
- K873271 — DIGICELL 300 SYSTEM
- K872166 — FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
- K871830 — NAPSAC(TM)
- K873103 — TECHNICON H*1 JR.(TM) SYSTEM
- K870603 — SYSTEM 9000 AUTOMATED CELL COUNTER
- K863332 — ATAC 4300 HEMATOLOGY CELL COUNTER
- K862374 — CELLECT 8E AUTOMATED BLOOD CELL COUNTERS
- K863084 — COULTER COUNTER MODEL T-890
- K863085 — COULTER COUNTER MODEL T-540
- K863290 — IL CELLECT 7
- K863291 — IL CELLECT 8
- K861780 — COULTER COUNTER MODEL S PLUS JUNIOR
- K860586 — PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS
- K860166 — PICOSCALE BLOOD CELL COUNTER, MODEL PS-5
- K854677 — ERMA PC-604 BLOOD CELL COUNTER
- K854678 — ERMA PC-602 PC-603 BLOOD CELL COUNTER
- K853030 — TECHNICON H*1 SYSTEM (HDW)
- K853722 — PLT-4 PLATELET ANALYZER
- K853036 — PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1
- K854114 — COULTER COUNTER MODEL T-660
- K853429 — COULTER COUNTER MODEL M5
- K851943 — COULTER VOLUME ADAPTER
- K851736 — COULTER CHANNELYZER 256
- K850171 — SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS
- K850386 — SYSTEM 8000 CELL COUNTER
- K845019 — CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER
- K841803 — A1 SYSTEME 8201/2
- K843303 — COULTER COUNTER MODEL M4
- K843164 — COULTER COUNTER MODEL ZM
- K844042 — BLOOD DILUTION VIAL
- K842140 — PICOSCAL BLOOD CELL COUNTER PS-4
- K842346 — COULTER AUTOMATIC SAMPLE HANDLER
- K840649 — DANAM ELEC. SA-1000
- K841504 — QUICK-COUNT PLUS 2
- K840658 — QBC CENTRIFUGAL HEMATOLOGY ANALYZ
- K840170 — CELL-DYN 100 WHOLE BLOOD PLATELET
- K834372 — PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ
- K834568 — COULTER COUNTER M2
- K833971 — QUICK-COUNT
- K834026 — RDW PARAMETER FOR THE TECHNICON H6000
- K832890 — HEMACOMP 7 OR HEMATIL 7
- K832643 — CELL-DYN 900 HEMATOLOGY ANALYZER
- K832627 — TECHNICON H6000 SYSTEM
- K832420 — FACS ANALYZER
- K831368 — CELL-DYN 400 HEMOTOLOGY ANALYZER
- K832038 — CELL-DYN 300 HEMATOLOGY ANALYZER
- K830507 — SYSMEX CC-170
- K830505 — SYSMEX CC-130
- K830506 — SYSMEX CC-150
- K830508 — SYSMEX CC-180
- K830451 — QBC CENTRIFUGAL HEMATOLOGY SYS
- K823886 — PROFILE 750 BLOOD CELL COUNTER
- K823344 — HEMATOLOGY ANALYZER
- K822758 — SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY
- K821575 — SYSMEX CC-800
- K821238 — CC-700 SEVEN PARAMETER, AUTOMATED HEMAA
- K811978 — TECHNICON H6000 (90/HR) HEMATOLOGY SYS
- K812031 — LPC II
- K803071 — PLA-MATE
- K803218 — CELL DYN 800 HEMATOLOGY ANALYZER
- K803128 — SERIES 810 PLATELET ANALYZER
- K802636 — PLATELET COUNTING KIT
- K802094 — ORTHO SPECTRUM
Data sourced from openFDA. This site is unofficial and independent of the FDA.