FDA 510(k) Applications for Medical Device Product Code: KQO (Automated Urinalysis System)

FDA 510(k) Applications for Medical Device Product Code "KQO"
(Automated Urinalysis System)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K070929	ACON LABORATORIES, INC.	ACON U120 URINE ANALYZER, MODEL U111-101	07/30/2007
K142543	ACON LABORATORIES, INC.	Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control	05/11/2015
K091472	ARJ MEDICAL, INC.	URITEST 50 AND URITEST 500 URINE ANALYZER	04/27/2010
K121456	ARKRAY, INC.	AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL	02/01/2013
K093098	ARKRAY, INC.	AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM	12/23/2009
K960546	BAYER CORP.	CLINITEK 50 URINE CHEMISTRY ANALYZER	06/12/1996
K031947	BAYER HEALTHCARE, LLC	BAYER CLINITEK STATUS ANALYZER	12/19/2003
K012829	BIOCARE CORP.	STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS	11/02/2001
K983510	BOEHRINGER MANNHEIM CORP.	CHEMSTRIP 101 URINE ANALYZER	10/27/1998
K951877	CHIMERA RESEARCH & CHEMICAL, INC.	AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE	05/14/1996
K102188	DFI CO., LTD.	CYBOW READER, MODELS 300 & 720	08/09/2011
K053253	HEMOCUE AB	HEMOCUE ALBUMIN 201 ANALYZING SYSTEM	02/17/2006
K030600	INTERNATIONAL REMOTE IMAGING SYSTEMS	AUTION JET AJ-4270 URINE ANALYZER	07/11/2003
K013783	INTERNATIONAL REMOTE IMAGING SYSTEMS	AUTION MAX AX-4280 URINALYSIS SYSTEM	01/18/2002
K960054	INTL. REMOTE IMAGING SYSTEMS	900UDX URINE PATHOLOGY SYSTEM	03/22/1996
K972141	INTL. REMOTE IMAGING SYSTEMS	THE YELLOW IRIS URINALYSIS WORKSTATION	08/25/1997
K101852	IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	03/23/2011
K093555	Roche Diagnostics	COBAS U411 TEST SYSTEM	04/02/2010
K954514	Sciteck Diagnostics, Inc.	UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE	06/21/1996
K140717	SIEMENS HEALTHCARE DIAGNOSTICS	CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT	11/17/2014
K954158	SOLARCARE TECHNOLOGIES CORP,INC.	STC DIAGNOSTICS AUTO-LYTE PH ASSAY	04/30/1996
K954156	SOLARCARE TECHNOLOGIES CORP,INC.	STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY	07/22/1996
K042421	TECO DIAGNOSTICS	URITEK 151 URINE ANALYZER, MODEL TC-151	05/09/2005
K051526	TECO DIAGNOSTICS	URITEK-720+ URINE ANALYZER	08/16/2005
K141874	YD DIAGNOSTICS CORP.	URISCAN OPTIMA	05/28/2015
K980047	YEONGDONG PHARMACEUTICAL CORP.	URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER	06/10/1998

FDA 510(k) Applications for Medical Device Product Code "KQO" (Automated Urinalysis System)

FDA 510(k) Applications for Medical Device Product Code "KQO"
(Automated Urinalysis System)