KQO · Class I · 21 CFR 862.2900

FDA Product Code KQO: Automated Urinalysis System

Leading manufacturers include Miles Laboratories, Inc., Boehringer Mannheim Corp. and Teco Diagnostics.

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 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 Apr 02, 2010
COBAS U411 TEST SYSTEM
K093555
Roche Diagnostics
Chemistry · 136d
Cleared Jul 30, 2007
ACON U120 URINE ANALYZER, MODEL U111-101
K070929
ACON Laboratories, Inc.
Chemistry · 118d
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 Jul 22, 1996
STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
K954156
Solarcare Technologies Corp,Inc.
Chemistry · 321d
Cleared Jun 12, 1996
CLINITEK 50 URINE CHEMISTRY ANALYZER
K960546
Bayer Corp.
Chemistry · 125d
Cleared Apr 30, 1996
STC DIAGNOSTICS AUTO-LYTE PH ASSAY
K954158
Solarcare Technologies Corp,Inc.
Chemistry · 238d
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
Cleared Oct 14, 1993
CHEMSTRIP SUPER UA URINE ANALYZER
K934042
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Jun 15, 1993
CHEMSTRIP URINE ANALYZER
K931602
Boehringer Mannheim Corp.
Chemistry · 75d
Cleared Jan 28, 1993
CLINITEK 200+ URINE CHEMISTRY ANALYZER
K926359
Heraeus Kulzer, Inc.
Chemistry · 38d
Cleared Mar 24, 1992
CHEMSTRIP URINE ANALYZER
K921087
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Aug 24, 1984
CLINI-TEK AUTO 2000 REFLECTANCE SPECTR
K841041
Miles Laboratories, Inc.
Chemistry · 165d
Cleared Aug 15, 1984
CLINITEK 200 SEMI-AUTOMATED URINALYSIS
K842237
Miles Laboratories, Inc.
Chemistry · 71d
Cleared Jul 25, 1984
CLINITEK 10 SEMI-AUTO URINALYSIS SYS
K842238
Miles Laboratories, Inc.
Chemistry · 50d
Cleared Jul 06, 1982
CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST
K821738
Miles Laboratories, Inc.
Chemistry · 22d
Cleared Mar 21, 1977
CLINILAB AUTOMATED URINALYSIS SYSTEM
K761306
Miles Laboratories, Inc.
Chemistry · 89d
Cleared Oct 29, 1976
INSTRUMENTED SYSTEM FOR URINALYSIS
K760472
Miles Laboratories, Inc.
Chemistry · 71d

About Product Code KQO - Regulatory Context