KQO · Class I · 21 CFR 862.2900

FDA Product Code KQO: Automated Urinalysis System

Leading manufacturers include Miles Laboratories, Inc., Boehringer Mannheim Corp. and Solarcare Technologies Corp,Inc..

46
Total
46
Cleared
143d
Avg days
1976
Since

FDA 510(k) Cleared Automated Urinalysis System Devices (Product Code KQO)

46 devices
1–24 of 46
Cleared May 28, 2015
URISCAN OPTIMA
K141874
Yd Diagnostics Corp.
Chemistry · 321d
Cleared May 11, 2015
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
K142543
ACON Laboratories, Inc.
Chemistry · 243d
Cleared Nov 17, 2014
CLINITEK NOVUS
K140717
Siemens Healthcare Diagnostics
Chemistry · 242d
Cleared Feb 01, 2013
AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM
K121456
Arkray, Inc.
Chemistry · 261d
Cleared Apr 27, 2010
URITEST 50 AND URITEST 500 URINE ANALYZER
K091472
Arj Medical, Inc.
Chemistry · 344d
Cleared Apr 02, 2010
COBAS U411 TEST SYSTEM
K093555
Roche Diagnostics
Chemistry · 136d
Cleared Dec 23, 2009
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM
K093098
Arkray, Inc.
Chemistry · 83d
Cleared Jul 30, 2007
ACON U120 URINE ANALYZER, MODEL U111-101
K070929
ACON Laboratories, Inc.
Chemistry · 118d
Cleared Feb 17, 2006
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
K053253
Hemocue AB
Chemistry · 88d
Cleared Aug 16, 2005
URITEK-720+ URINE ANALYZER
K051526
Teco Diagnostics
Chemistry · 69d
Cleared May 09, 2005
URITEK 151 URINE ANALYZER, MODEL TC-151
K042421
Teco Diagnostics
Chemistry · 244d
Cleared Dec 19, 2003
BAYER CLINITEK STATUS ANALYZER
K031947
Bayer Healthcare, LLC
Chemistry · 178d
Cleared Oct 27, 1998
CHEMSTRIP 101 URINE ANALYZER
K983510
Boehringer Mannheim Corp.
Chemistry · 20d
Cleared Jun 10, 1998
URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER
K980047
Yeongdong Pharmaceutical Corp.
Chemistry · 155d
Cleared Aug 25, 1997
THE YELLOW IRIS URINALYSIS WORKSTATION
K972141
Intl. Remote Imaging Systems
Chemistry · 80d
Cleared Jul 22, 1996
STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
K954156
Solarcare Technologies Corp,Inc.
Chemistry · 321d
Cleared Jun 21, 1996
UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE
K954514
Sciteck Diagnostics, Inc.
Chemistry · 267d
Cleared Jun 12, 1996
CLINITEK 50 URINE CHEMISTRY ANALYZER
K960546
Bayer Corp.
Chemistry · 125d
Cleared May 14, 1996
AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE
K951877
Chimera Research & Chemical, Inc.
Chemistry · 403d
Cleared Apr 30, 1996
STC DIAGNOSTICS AUTO-LYTE PH ASSAY
K954158
Solarcare Technologies Corp,Inc.
Chemistry · 238d
Cleared Mar 22, 1996
900UDX URINE PATHOLOGY SYSTEM
K960054
Intl. Remote Imaging Systems
Hematology · 78d
Cleared Oct 23, 1995
CHEMSTRIP CRITERION URINE ANALYZER
K954024
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Feb 22, 1995
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER
K946183
Heraeus Kulzer, Inc.
Chemistry · 64d
Cleared Nov 08, 1994
CHEMSTRIP MINI UA URINE ANALYZER
K943592
Boehringer Mannheim Corp.
Chemistry · 106d

About Product Code KQO - Regulatory Context