510(k) K962988
- Device
- COULTER GEN-S SYSTEM
- Applicant
- COULTER CORP.
- 510(k) number
- K962988
- Product code
- GKL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-30
- Date received
- 1996-08-01
- Regulation
- 864.5200
- Classification name
- Counter, Cell, Automated (particle Counter)
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS J ENGLISH
- Address
- 11800 SW 147th Ave. Mail Code 31-B06 Miami FL US 33196 33196
FDA Registration Numbers#
- 3013660430
- 3006198300
- 1181121
- 3003044483
- 2432235
- 3008352382
- 9613959
- 2914537
- 3010421384
- 1221433
- 3009711478
- 3027394506
- 1950302
- 2122870
- 1061932
- 3005146144
- 1217058
- 3002759288
- 8020888
- 3020704087
- 3000148879
Source Documents#
Other 510(k) Records For Product Code GKL #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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