GKL — Counter, Cell, Automated (Particle Counter) Class II
FDA product code GKL covers "Counter, Cell, Automated (Particle Counter)", a Class II medical device regulated under 21 CFR 864.5200. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GKL
- Device Class
- Class II
- Regulation Number
- 864.5200
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K152776 | advanced instruments | Glocyte Automated Cell Counter System | May 27, 2016 |
| K091539 | iris diagnostics | IQ 200 URINE ANALIZER BODY FLUIDS MODULE | August 31, 2010 |
| K071652 | hemocue | HEMOCUE WBC SYSTEM | October 25, 2007 |
| K051693 | bayer healthcare | MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM | December 7, 2005 |
| K050235 | iris international | IQ 200 URINE ANALYZER BODY FLUIDS MODULE | March 23, 2005 |
| K032677 | sysmex america | SYSMEX POCH-100I | February 11, 2004 |
| K022331 | bayer diagnostics | ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD | September 11, 2002 |
| K001683 | sysmex corporation of america | SYSMEX R-500 | August 21, 2000 |
| K991070 | coulter | COULTER Z2 ANALYZER | May 11, 1999 |
| K981950 | sysmex | SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 | November 3, 1998 |
| K981761 | sysmex | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER | August 14, 1998 |
| K971998 | bayer | ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM | August 29, 1997 |
| K964375 | sysmex | SYSMEX SE/RAM-1 | March 13, 1997 |
| K962988 | coulter | COULTER GEN-S SYSTEM | October 30, 1996 |
| K954607 | bayer | RETICULOCYTE METHOD | August 30, 1996 |
| K954006 | intl. remote imaging systems | YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY | March 12, 1996 |
| K952308 | coulter | COULTER Z 1 | October 6, 1995 |
| K934539 | intl. remote imaging systems | THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABIL | March 30, 1994 |
| K930685 | heraeus kulzer | TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) | June 22, 1993 |
| K923121 | bd becton dickinson vacutainer systems preanalytic | QBC HEMACAN HEMATOLOGY SYSTEM | September 22, 1992 |