Product code GKL
- Device name
- Counter, Cell, Automated (Particle Counter)
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.5200
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152776 | Glocyte Automated Cell Counter System | Advanced Instruments, Inc. | 2016-05-27 |
| K091539 | IQ 200 URINE ANALIZER BODY FLUIDS MODULE | Iris Diagnostics | 2010-08-31 |
| K071652 | HEMOCUE WBC SYSTEM | Hemocue AB | 2007-10-25 |
| K051693 | MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM | Bayer Healthcare, LLC | 2005-12-07 |
| K050235 | IQ 200 URINE ANALYZER BODY FLUIDS MODULE | Iris International, Inc. | 2005-03-23 |
| K032677 | SYSMEX POCH-100I | Sysmex America, Inc. | 2004-02-11 |
| K022331 | ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD | Bayer Diagnostics Corp. | 2002-09-11 |
| K001683 | SYSMEX R-500 | Sysmex Corporation of America | 2000-08-21 |
| K991070 | COULTER Z2 ANALYZER | Coulter Corp. | 1999-05-11 |
| K981950 | SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 | Sysmex Corp. | 1998-11-03 |
| K981761 | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER | Sysmex Corp. | 1998-08-14 |
| K971998 | ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM | Bayer Corp. | 1997-08-29 |
| K964375 | SYSMEX SE/RAM-1 | Sysmex Corp. | 1997-03-13 |
| K962988 | COULTER GEN-S SYSTEM | Coulter Corp. | 1996-10-30 |
| K954607 | RETICULOCYTE METHOD | Bayer Corp. | 1996-08-30 |
| K954006 | YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY | Intl. Remote Imaging Systems | 1996-03-12 |
| K952308 | COULTER Z 1 | Coulter Corp. | 1995-10-06 |
| K934539 | THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY | Intl. Remote Imaging Systems | 1994-03-30 |
| K930685 | TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) | Heraeus Kulzer, Inc. | 1993-06-22 |
| K923121 | QBC HEMACAN HEMATOLOGY SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-09-22 |
| K920719 | IVOS ANALYZER | Hamilton Thorne Research | 1992-06-29 |
| K914256 | YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU | Intl. Remote Imaging Systems | 1992-05-01 |
| K912494 | SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER | Toa Medical Electronics USA, Inc. | 1991-09-10 |
| K911173 | SYSMEX F-310 | Toa Medical Electronics USA, Inc. | 1991-07-26 |
| K911172 | SYSMEX F-610 | Toa Medical Electronics USA, Inc. | 1991-07-26 |
| K910849 | SYSMEX F-810 | Toa Medical Electronics USA, Inc. | 1991-07-26 |
| K910679 | GENESIS I AUTOMATED CELL COUNTER | Alicia Diagnostics, Inc. | 1991-05-07 |
| K894539 | SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER | Toa Medical Electronics USA, Inc. | 1989-09-26 |
| K885332 | COULTER FLOW RETICULOCYTE REAGENT | Coulter Electronics, Inc. | 1989-02-22 |
| K884618 | NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS | Nova Biomedical Corp. | 1989-01-24 |
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| 10816068020211 | Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit | Advanced Instruments, LLC | 2016-09-23 |
| 20816068020201 | Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays | Advanced Instruments, LLC | 2016-09-23 |
| 00816068020146 | Advanced Instruments GloCyte® Instrument Assembly | Advanced Instruments, LLC | 2016-09-23 |
| 00816068020139 | Advanced Instruments GloCyte® Automated Cell Counter System | Advanced Instruments, LLC | 2016-09-23 |
| 15099590250690 | COULTER Latron | Beckman Coulter, Inc. | 2016-09-23 |
| 15099590250683 | COULTER Latron | Beckman Coulter, Inc. | 2016-09-23 |
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| 10837461002475 | iQ®200 | BECKMAN COULTER IRELAND INC. | 2016-09-07 |
| 04987562402021 | Automated Hematology Analyzer pocH-100i | SYSMEX CORPORATION | 2016-08-04 |
| 04987562429219 | Automated Hematology Analyzer XP series XP-300 | SYSMEX CORPORATION | 2016-08-04 |
| 07311091230010 | HemoCue® WBC Analyzer | Hemocue AB | 2016-05-31 |
| 07311091130037 | HemoCue® WBC Microcuvettes | Hemocue AB | 2016-05-31 |
| 17311091130034 | HemoCue® WBC Microcuvettes | Hemocue AB | 2016-05-31 |