FDA 510(k) Applications for Medical Device Product Code: GKL (Counter, Cell, Automated (Particle Counter))

FDA 510(k) Applications for Medical Device Product Code "GKL"
(Counter, Cell, Automated (Particle Counter))

FDA 510(k) Number	Applicant	Device Name	Decision Date
K152776	Advanced Instruments, Inc.	Glocyte Automated Cell Counter System	05/27/2016
K971998	BAYER CORP.	ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM	08/29/1997
K954607	BAYER CORP.	RETICULOCYTE METHOD	08/30/1996
K022331	BAYER DIAGNOSTICS CORP.	ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD	09/11/2002
K051693	BAYER HEALTHCARE, LLC	MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM	12/07/2005
K962988	COULTER CORP.	COULTER GEN-S SYSTEM	10/30/1996
K991070	COULTER CORP.	COULTER Z2 ANALYZER	05/11/1999
K071652	HEMOCUE AB	HEMOCUE WBC SYSTEM	10/25/2007
K954006	INTL. REMOTE IMAGING SYSTEMS	YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY	03/12/1996
K091539	IRIS DIAGNOSTICS	IQ 200 URINE ANALIZER BODY FLUIDS MODULE	08/31/2010
K050235	IRIS INTERNATIONAL, INC.	IQ 200 URINE ANALYZER BODY FLUIDS MODULE	03/23/2005
K032677	SYSMEX AMERICA, INC.	SYSMEX POCH-100I	02/11/2004
K981761	SYSMEX CORP.	SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER	08/14/1998
K981950	SYSMEX CORP.	SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500	11/03/1998
K964375	SYSMEX CORP.	SYSMEX SE/RAM-1	03/13/1997
K001683	SYSMEX CORPORATION OF AMERICA	SYSMEX R-500	08/21/2000