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
K954514 CHIMERA RESEARCH & CHEMICAL, INC. UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE 06/21/1996
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
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


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