Panels › Hematology › Product code GKL · Class 2
Counter, Cell, Automated (Particle Counter)
Regulation 864.5200
0510(k)s in 12 months (130 all time)
0recalls in 12 months (10 all time)
7recalls that name a 510(k)
Top companies in GKL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 27, 2016 | K152776 | Glocyte Automated Cell Counter System Advanced Instruments, Inc. | GKL |
| Aug 31, 2010 | K091539 | IQ 200 URINE ANALIZER BODY FLUIDS MODULE Iris Diagnostics | GKL |
| Oct 25, 2007 | K071652 | HEMOCUE WBC SYSTEM Hemocue AB | GKL |
| Dec 7, 2005 | K051693 | MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM Bayer Healthcare, LLC | GKL |
| Mar 23, 2005 | K050235 | IQ 200 URINE ANALYZER BODY FLUIDS MODULE Iris International, Inc. | GKL |
| Feb 11, 2004 | K032677 | SYSMEX POCH-100I Sysmex America, Inc. | GKL |
| Sep 11, 2002 | K022331 | ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD Bayer Diagnostics Corp. | GKL |
| Aug 21, 2000 | K001683 | SYSMEX R-500 Sysmex Corporation of America | GKL |
| May 11, 1999 | K991070 | COULTER Z2 ANALYZER Coulter Corp. | GKL |
| Nov 3, 1998 | K981950 | SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 Sysmex Corp. | GKL |
| Aug 14, 1998 | K981761 | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER Sysmex Corp. | GKL |
| Aug 29, 1997 | K971998 | ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM Bayer Corp. | GKL |
| Mar 13, 1997 | K964375 | SYSMEX SE/RAM-1 Sysmex Corp. | GKL |
| Oct 30, 1996 | K962988 | COULTER GEN-S SYSTEM Coulter Corp. | GKL |
| Aug 30, 1996 | K954607 | RETICULOCYTE METHOD Bayer Corp. | GKL |
| Mar 12, 1996 | K954006 | YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY Intl. Remote Imaging Systems | GKL |
| Oct 6, 1995 | K952308 | COULTER Z 1 Coulter Corp. | GKL |
| Mar 30, 1994 | K934539 | THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY Intl. Remote Imaging Systems | GKL |
| Jun 22, 1993 | K930685 | TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) Heraeus Kulzer, Inc. | GKL |
| Sep 22, 1992 | K923121 | QBC HEMACAN HEMATOLOGY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | GKL |
| Jun 29, 1992 | K920719 | IVOS ANALYZER Hamilton Thorne Research | GKL |
| May 1, 1992 | K914256 | YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU Intl. Remote Imaging Systems | GKL |
| Sep 10, 1991 | K912494 | SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER Toa Medical Electronics USA, Inc. | GKL |
| Jul 26, 1991 | K911173 | SYSMEX F-310 Toa Medical Electronics USA, Inc. | GKL |
| Jul 26, 1991 | K911172 | SYSMEX F-610 Toa Medical Electronics USA, Inc. | GKL |
| Jul 26, 1991 | K910849 | SYSMEX F-810 Toa Medical Electronics USA, Inc. | GKL |
| May 7, 1991 | K910679 | GENESIS I AUTOMATED CELL COUNTER Alicia Diagnostics, Inc. | GKL |
| Sep 26, 1989 | K894539 | SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER Toa Medical Electronics USA, Inc. | GKL |
| Feb 22, 1989 | K885332 | COULTER FLOW RETICULOCYTE REAGENT Coulter Electronics, Inc. | GKL |
| Jan 24, 1989 | K884618 | NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS Nova Biomedical Corp. | GKL |
| Dec 28, 1988 | K885132 | FACSMATE SAMPLE HANDLING DEVICE Bd Becton Dickinson Vacutainer Systems Preanalytic | GKL |
| Dec 27, 1988 | K884471 | KVM BLOOD CELL COUNTER Kvm Instruments, Inc. | GKL |
| Mar 21, 1988 | K880636 | RETICCOUNT SOFTWARE Bd Becton Dickinson Vacutainer Systems Preanalytic | GKL |
| Jan 27, 1988 | K874320 | CELLECT LABTRAK SOFTWARE Instrumentation Laboratory CO | GKL |
| Nov 13, 1987 | K872145 | CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000) Cryo Corp. | GKL |
| Nov 6, 1987 | K873271 | DIGICELL 300 SYSTEM Contraves Medical Instruments, Inc. | GKL |
| Nov 6, 1987 | K873252 | DIGICELL 500 Contraves Medical Instruments, Inc. | GKL |
| Nov 6, 1987 | K873172 | HAMILTON-THORN MOTILITY ANALYZER HTM-2000 Hamilton Thorne Research | GKL |
| Sep 30, 1987 | K872166 | FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT Bd Becton Dickinson Vacutainer Systems Preanalytic | GKL |
| Sep 9, 1987 | K871830 | NAPSAC(TM) Beecher Medical Diagnostic Instrumentation | GKL |
| Aug 28, 1987 | K873103 | TECHNICON H*1 JR.(TM) SYSTEM Technicon Instruments Corp. | GKL |
| Mar 31, 1987 | K870603 | SYSTEM 9000 AUTOMATED CELL COUNTER Baker Instructions Corp. | GKL |
| Sep 29, 1986 | K863332 | ATAC 4300 HEMATOLOGY CELL COUNTER Turpen Laboratory Systems, Inc. | GKL |
| Sep 4, 1986 | K863291 | IL CELLECT 8 Instrumentation Laboratory CO | GKL |
| Sep 4, 1986 | K863290 | IL CELLECT 7 Instrumentation Laboratory CO | GKL |
| Sep 4, 1986 | K863085 | COULTER COUNTER MODEL T-540 Coulter Electronics, Inc. | GKL |
| Sep 4, 1986 | K863084 | COULTER COUNTER MODEL T-890 Coulter Electronics, Inc. | GKL |
| Sep 4, 1986 | K862374 | CELLECT 8E AUTOMATED BLOOD CELL COUNTERS Instrumentation Laboratory CO | GKL |
| Aug 6, 1986 | K861780 | COULTER COUNTER MODEL S PLUS JUNIOR Coulter Electronics, Inc. | GKL |
| May 7, 1986 | K860586 | PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS Diagnostic Technology, Inc. | GKL |
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