FDA Product Code
FDA Product Code GKL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5200
510(k) Clearances — 130 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K152776 | Glocyte Automated Cell Counter System | Advanced Instruments, Inc. | 2016-05-27 | Traditional | PDF ↗ |
| K091539 | IQ 200 URINE ANALIZER BODY FLUIDS MODULE | Iris Diagnostics | 2010-08-31 | Traditional | PDF ↗ |
| K071652 | HEMOCUE WBC SYSTEM | Hemocue AB | 2007-10-25 | Traditional | PDF ↗ |
| K051693 | MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM | Bayer Healthcare, LLC | 2005-12-07 | Traditional | PDF ↗ |
| K050235 | IQ 200 URINE ANALYZER BODY FLUIDS MODULE | Iris International, Inc. | 2005-03-23 | Traditional | PDF ↗ |
| K032677 | SYSMEX POCH-100I | Sysmex America, Inc. | 2004-02-11 | Traditional | PDF ↗ |
| K022331 | ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD | Bayer Diagnostics Corp. | 2002-09-11 | Special | PDF ↗ |
| K001683 | SYSMEX R-500 | Sysmex Corporation of America | 2000-08-21 | Traditional | PDF ↗ |
| K991070 | COULTER Z2 ANALYZER | Coulter Corp. | 1999-05-11 | Traditional | PDF ↗ |
| K981950 | SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 | Sysmex Corp. | 1998-11-03 | Traditional | PDF ↗ |
| K981761 | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER | Sysmex Corp. | 1998-08-14 | Traditional | PDF ↗ |
| K971998 | ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM | Bayer Corp. | 1997-08-29 | Traditional | PDF ↗ |
| K964375 | SYSMEX SE/RAM-1 | Sysmex Corp. | 1997-03-13 | Traditional | PDF ↗ |
| K962988 | COULTER GEN-S SYSTEM | Coulter Corp. | 1996-10-30 | Traditional | PDF ↗ |
| K954607 | RETICULOCYTE METHOD | Bayer Corp. | 1996-08-30 | Traditional | PDF ↗ |
| K954006 | YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY | Intl. Remote Imaging Systems | 1996-03-12 | Traditional | PDF ↗ |
| K952308 | COULTER Z 1 | Coulter Corp. | 1995-10-06 | Traditional | PDF ↗ |
| K934539 | THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY | Intl. Remote Imaging Systems | 1994-03-30 | Traditional | PDF ↗ |
| K930685 | TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) | Heraeus Kulzer, Inc. | 1993-06-22 | Traditional | PDF ↗ |
| K923121 | QBC HEMACAN HEMATOLOGY SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-09-22 | Traditional | PDF ↗ |
| K920719 | IVOS ANALYZER | Hamilton Thorne Research | 1992-06-29 | Traditional | PDF ↗ |
| K914256 | YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU | Intl. Remote Imaging Systems | 1992-05-01 | Traditional | PDF ↗ |
| K912494 | SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER | Toa Medical Electronics USA, Inc. | 1991-09-10 | Traditional | PDF ↗ |
| K911172 | SYSMEX F-610 | Toa Medical Electronics USA, Inc. | 1991-07-26 | Traditional | PDF ↗ |
| K911173 | SYSMEX F-310 | Toa Medical Electronics USA, Inc. | 1991-07-26 | Traditional | PDF ↗ |
| K910849 | SYSMEX F-810 | Toa Medical Electronics USA, Inc. | 1991-07-26 | Traditional | PDF ↗ |
| K910679 | GENESIS I AUTOMATED CELL COUNTER | Alicia Diagnostics, Inc. | 1991-05-07 | Traditional | PDF ↗ |
| K894539 | SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER | Toa Medical Electronics USA, Inc. | 1989-09-26 | Traditional | PDF ↗ |
| K885332 | COULTER FLOW RETICULOCYTE REAGENT | Coulter Electronics, Inc. | 1989-02-22 | Traditional | PDF ↗ |
| K884618 | NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS | Nova Biomedical Corp. | 1989-01-24 | Traditional | PDF ↗ |
| K885132 | FACSMATE SAMPLE HANDLING DEVICE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-12-28 | Traditional | PDF ↗ |
| K884471 | KVM BLOOD CELL COUNTER | Kvm Instruments, Inc. | 1988-12-27 | Traditional | PDF ↗ |
| K880636 | RETICCOUNT SOFTWARE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-03-21 | Traditional | PDF ↗ |
| K874320 | CELLECT LABTRAK SOFTWARE | Instrumentation Laboratory CO | 1988-01-27 | Traditional | PDF ↗ |
| K872145 | CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000) | Cryo Corp. | 1987-11-13 | Traditional | PDF ↗ |
| K873252 | DIGICELL 500 | Contraves Medical Instruments, Inc. | 1987-11-06 | Traditional | PDF ↗ |
| K873271 | DIGICELL 300 SYSTEM | Contraves Medical Instruments, Inc. | 1987-11-06 | Traditional | PDF ↗ |
| K873172 | HAMILTON-THORN MOTILITY ANALYZER HTM-2000 | Hamilton Thorne Research | 1987-11-06 | Traditional | PDF ↗ |
| K872166 | FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-09-30 | Traditional | PDF ↗ |
| K871830 | NAPSAC(TM) | Beecher Medical Diagnostic Instrumentation | 1987-09-09 | Traditional | PDF ↗ |
| K873103 | TECHNICON H*1 JR.(TM) SYSTEM | Technicon Instruments Corp. | 1987-08-28 | Traditional | PDF ↗ |
| K870603 | SYSTEM 9000 AUTOMATED CELL COUNTER | Baker Instructions Corp. | 1987-03-31 | Traditional | PDF ↗ |
| K863332 | ATAC 4300 HEMATOLOGY CELL COUNTER | Turpen Laboratory Systems, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K863290 | IL CELLECT 7 | Instrumentation Laboratory CO | 1986-09-04 | Traditional | PDF ↗ |
| K862374 | CELLECT 8E AUTOMATED BLOOD CELL COUNTERS | Instrumentation Laboratory CO | 1986-09-04 | Traditional | PDF ↗ |
| K863291 | IL CELLECT 8 | Instrumentation Laboratory CO | 1986-09-04 | Traditional | PDF ↗ |
| K863084 | COULTER COUNTER MODEL T-890 | Coulter Electronics, Inc. | 1986-09-04 | Traditional | PDF ↗ |
| K863085 | COULTER COUNTER MODEL T-540 | Coulter Electronics, Inc. | 1986-09-04 | Traditional | PDF ↗ |
| K861780 | COULTER COUNTER MODEL S PLUS JUNIOR | Coulter Electronics, Inc. | 1986-08-06 | Traditional | PDF ↗ |
| K860586 | PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS | Diagnostic Technology, Inc. | 1986-05-07 | Traditional | PDF ↗ |
| K860166 | PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 | Diagnostic Technology, Inc. | 1986-04-04 | Traditional | PDF ↗ |
| K854678 | ERMA PC-602 PC-603 BLOOD CELL COUNTER | Future Impex Corp. | 1986-02-24 | Traditional | PDF ↗ |
| K854677 | ERMA PC-604 BLOOD CELL COUNTER | Future Impex Corp. | 1986-02-24 | Traditional | PDF ↗ |
| K853030 | TECHNICON H*1 SYSTEM (HDW) | Technicon Instruments Corp. | 1986-02-05 | Traditional | PDF ↗ |
| K853722 | PLT-4 PLATELET ANALYZER | Texas Intl. Laboratories, Inc. | 1986-01-17 | Traditional | PDF ↗ |
| K853036 | PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 | Diagnostic Technology, Inc. | 1985-11-05 | Traditional | PDF ↗ |
| K854114 | COULTER COUNTER MODEL T-660 | Coulter Electronics, Inc. | 1985-11-05 | Traditional | PDF ↗ |
| K853429 | COULTER COUNTER MODEL M5 | Coulter Electronics, Inc. | 1985-10-10 | Traditional | PDF ↗ |
| K851943 | COULTER VOLUME ADAPTER | Coulter Electronics, Inc. | 1985-08-30 | Traditional | PDF ↗ |
| K851736 | COULTER CHANNELYZER 256 | Coulter Electronics, Inc. | 1985-07-30 | Traditional | PDF ↗ |
| K850171 | SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS | Toa Medical Electronics USA, Inc. | 1985-05-13 | Traditional | PDF ↗ |
| K850386 | SYSTEM 8000 CELL COUNTER | Baker Instructions Corp. | 1985-05-02 | Traditional | PDF ↗ |
| K845019 | CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER | Abbott Diagnostics | 1985-03-26 | Traditional | PDF ↗ |
| K841803 | A1 SYSTEME 8201/2 | Med USA | 1985-02-25 | Traditional | PDF ↗ |
| K843303 | COULTER COUNTER MODEL M4 | Coulter Electronics, Inc. | 1984-12-05 | Traditional | PDF ↗ |
| K843164 | COULTER COUNTER MODEL ZM | Coulter Electronics, Inc. | 1984-11-13 | Traditional | PDF ↗ |
| K844042 | BLOOD DILUTION VIAL | American Scientific Products | 1984-10-23 | Traditional | PDF ↗ |
| K842140 | PICOSCAL BLOOD CELL COUNTER PS-4 | Diagnostic Technology, Inc. | 1984-08-16 | Traditional | PDF ↗ |
| K842346 | COULTER AUTOMATIC SAMPLE HANDLER | Coulter Electronics, Inc. | 1984-07-27 | Traditional | PDF ↗ |
| K840649 | DANAM ELEC. SA-1000 | Danam Electronics | 1984-07-19 | Traditional | PDF ↗ |
| K841504 | QUICK-COUNT PLUS 2 | Seragen Diagnostics, Inc. | 1984-06-11 | Traditional | PDF ↗ |
| K840658 | QBC CENTRIFUGAL HEMATOLOGY ANALYZ | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-04-17 | Traditional | PDF ↗ |
| K840170 | CELL-DYN 100 WHOLE BLOOD PLATELET | Abbott Diagnostics | 1984-03-02 | Traditional | PDF ↗ |
| K834372 | PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ | Diagnostic Technology, Inc. | 1984-02-10 | Traditional | PDF ↗ |
| K834568 | COULTER COUNTER M2 | Coulter Electronics, Inc. | 1984-02-10 | Traditional | PDF ↗ |
| K834026 | RDW PARAMETER FOR THE TECHNICON H6000 | Technicon Instruments Corp. | 1984-01-30 | Traditional | PDF ↗ |
| K833971 | QUICK-COUNT | Seragen Diagnostics, Inc. | 1984-01-30 | Traditional | PDF ↗ |
| K832890 | HEMACOMP 7 OR HEMATIL 7 | Texas Intl. Laboratories, Inc. | 1983-10-19 | Traditional | PDF ↗ |
| K832643 | CELL-DYN 900 HEMATOLOGY ANALYZER | Abbott Diagnostics | 1983-09-26 | Traditional | PDF ↗ |
| K832627 | TECHNICON H6000 SYSTEM | Technicon Instruments Corp. | 1983-09-12 | Traditional | PDF ↗ |
| K832420 | FACS ANALYZER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-09-01 | Traditional | PDF ↗ |
| K832038 | CELL-DYN 300 HEMATOLOGY ANALYZER | Abbott Diagnostics | 1983-07-18 | Traditional | PDF ↗ |
| K831368 | CELL-DYN 400 HEMOTOLOGY ANALYZER | Abbott Diagnostics | 1983-07-18 | Traditional | PDF ↗ |
| K830507 | SYSMEX CC-170 | Toa Medical Electronics USA, Inc. | 1983-05-13 | Traditional | PDF ↗ |
| K830505 | SYSMEX CC-130 | Toa Medical Electronics USA, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K830506 | SYSMEX CC-150 | Toa Medical Electronics USA, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K830508 | SYSMEX CC-180 | Toa Medical Electronics USA, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K830451 | QBC CENTRIFUGAL HEMATOLOGY SYS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-04-27 | Traditional | PDF ↗ |
| K823886 | PROFILE 750 BLOOD CELL COUNTER | Mallinckrodt Critical Care | 1983-03-01 | Traditional | PDF ↗ |
| K823344 | HEMATOLOGY ANALYZER | Abbott Diagnostics | 1982-12-28 | Traditional | PDF ↗ |
| K822758 | SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY | Toa Medical Electronics USA, Inc. | 1982-10-18 | Traditional | PDF ↗ |
| K821575 | SYSMEX CC-800 | Sysmex/Toa Medical Electronics, Inc. | 1982-07-02 | Traditional | PDF ↗ |
| K821238 | CC-700 SEVEN PARAMETER, AUTOMATED HEMAA | Dysmex | 1982-05-28 | Traditional | PDF ↗ |
| K811978 | TECHNICON H6000 (90/HR) HEMATOLOGY SYS | Technicon Instruments Corp. | 1981-08-12 | Traditional | PDF ↗ |
| K812031 | LPC II | Labtronix Corp. | 1981-08-12 | Traditional | PDF ↗ |
| K803071 | PLA-MATE | Labex, Inc. | 1981-07-24 | Traditional | PDF ↗ |
| K803218 | CELL DYN 800 HEMATOLOGY ANALYZER | Abbott Diagnostics | 1981-06-09 | Traditional | PDF ↗ |
| K803128 | SERIES 810 PLATELET ANALYZER | J.T. Baker Chemical Co. | 1981-04-03 | Traditional | PDF ↗ |
| K802636 | PLATELET COUNTING KIT | Streck Laboratories, Inc. | 1980-12-11 | Traditional | PDF ↗ |
| K802094 | ORTHO SPECTRUM | Ortho Instruments | 1980-10-10 | Traditional | PDF ↗ |
Product code GKL · Class II · Hematology. Data: openFDA.