GKH

Product Code: GKH

Products Classified as GKH

2308

Apparatus, Automated Blood Cell Diluting

Automated Blood Cell Diluting Apparatus.

Total Product Life Cycle (TPLC) Devices

2308

Apparatus, Automated Blood Cell Diluting

Automated Blood Cell Diluting Apparatus.

Pre-market Notifications for GKH

K100684	CELLTRACKS AUTOPREP SYSTEM MODEL:9541	VERIDEX, LLC
K040077	IMMUNICON CELLTRACKS AUTOPREP SYSTEM	IMMUNICON CORP.
K935953	COULTER MULTI Q PREP	COULTER CORP.
K923530	COULTER MULTI-Q-PREP	COULTER ELECTRONICS, INC.
K904795	FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K882767	SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM	TOA MEDICAL ELECTRONICS USA, INC.
K852373	AD150, AUTOMATED HEMATOLOGY DILUTOR	ABBOTT DIAGNOSTICS
K842446	DILU-MATIC 140	ABBOTT DIAGNOSTICS
K823522	DILULAB 230	INNOVATIVE MEDICAL SYSTEMS, INC.

Global Unique Device Identification Database

• 08885016030003: Apparatus, Automated Blood Cell Diluting
• 08800021900035: Apparatus, Automated Blood Cell Diluting
• 08800021900028: Apparatus, Automated Blood Cell Diluting

Maude Adverse Events

CELLTRACKS AUTOPREP SYSTEM	VERIDEX LLC	2009-04-30
CELLTRACKS AUTOPREP SYSTEM	VERIDEX, LLC	2009-03-11
COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER	BECKMAN COULTER, INC.	2006-12-18
COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER	BECKMAN COULTER, INC.	2006-05-17
COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER	BECKMAN COULTER, INC.	2006-04-19
COULTER LH 750	BECKMAN COULTER, INC.	2005-07-15
COULTER LH 750	BECKMAN COULTER, INC.	2005-05-31
COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER	BECKMAN COULTER, INC.	2005-05-31
COULTER LH 750	BECKMAN COULTER, INC.	2005-04-13
BD FACS SAMPLE PROCESSOR SP-1	BD BIOSCIENCES	2004-09-10
COULTER LH 750	BECKMAN COULTER, INC.	2004-07-22
COULTER AC-T DIFF 2 HEMATOLOGY ANALYZER	BECKMAN COULTER, INC.	2003-10-14
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-09-16
**	*	2003-09-16
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-09-16
**	*	2003-09-16
**	ORTHO-CLINICAL DIAGNOSTICS, INC.	2003-08-13
**	ORTHO-CLINICAL DIAGNOSTICS, INC.	2003-08-13
**	ORTHO-CLINICAL DIAGNOSTICS, INC.	2003-08-13
**	ORTHO-CLINICAL DIAGNOSTICS, INC.	2003-08-13
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-08-13
		2003-08-13
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-07-24
		2003-07-24
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-07-24
		2003-07-24
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-07-24
		2003-07-24
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-07-24
		2003-07-24
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-07-24
**	*	2003-07-24
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-07-24
		2003-07-24
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-07-24
**	*	2003-07-24
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-07-24
**	*	2003-07-24
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-07-24
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-07-24
**	*	2003-07-24
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-07-24
**	*	2003-07-24
		2003-07-24
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-07-24
**	*	2003-07-24
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-07-24
**	*	2003-07-24
ORTHO SUMMIT PROCESSOR	ORTHO-CLINICAL DIAGNOSTICS	2003-07-24
		2003-07-24