KQO · Class I · 21 CFR 862.2900

FDA Product Code KQO: Automated Urinalysis System

Leading manufacturers include Miles Laboratories, Inc., Boehringer Mannheim Corp. and Heraeus Kulzer, 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 Apr 02, 2010
COBAS U411 TEST SYSTEM
K093555
Roche Diagnostics
Chemistry · 136d
Cleared Oct 27, 1998
CHEMSTRIP 101 URINE ANALYZER
K983510
Boehringer Mannheim Corp.
Chemistry · 20d
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