Panels › Clinical Chemistry › Product code KQO · Class 1
Automated Urinalysis System
Regulation 862.2900
0510(k)s in 12 months (46 all time)
2recalls in 12 months (35 all time)
24recalls that name a 510(k)
Top companies in KQO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 28, 2015 | K141874 | URISCAN OPTIMA Yd Diagnostics Corp., KR | KQO |
| May 11, 2015 | K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control ACON Laboratories, Inc. | KQO |
| Nov 17, 2014 | K140717 | CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT Siemens Healthcare Diagnostics | KQO |
| Feb 1, 2013 | K121456 | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL Arkray, Inc. | KQO |
| Aug 9, 2011 | K102188 | CYBOW READER, MODELS 300 & 720 DFI Co., Ltd., KR | KQO |
| Mar 23, 2011 | K101852 | CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT Iris International Inc., A Division of Iris Iris I | KQO |
| Apr 27, 2010 | K091472 | URITEST 50 AND URITEST 500 URINE ANALYZER Arj Medical, Inc. | KQO |
| Apr 2, 2010 | K093555 | COBAS U411 TEST SYSTEM Roche Diagnostics | KQO |
| Dec 23, 2009 | K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM Arkray, Inc. | KQO |
| Jul 30, 2007 | K070929 | ACON U120 URINE ANALYZER, MODEL U111-101 ACON Laboratories, Inc. | KQO |
| Feb 17, 2006 | K053253 | HEMOCUE ALBUMIN 201 ANALYZING SYSTEM Hemocue AB | KQO |
| Aug 16, 2005 | K051526 | URITEK-720+ URINE ANALYZER Teco Diagnostics | KQO |
| May 9, 2005 | K042421 | URITEK 151 URINE ANALYZER, MODEL TC-151 Teco Diagnostics | KQO |
| Dec 19, 2003 | K031947 | BAYER CLINITEK STATUS ANALYZER Bayer Healthcare, LLC | KQO |
| Jul 11, 2003 | K030600 | AUTION JET AJ-4270 URINE ANALYZER International Remote Imaging Systems | KQO |
| Jan 18, 2002 | K013783 | AUTION MAX AX-4280 URINALYSIS SYSTEM International Remote Imaging Systems | KQO |
| Nov 2, 2001 | K012829 | STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS Biocare Corp. | KQO |
| Oct 27, 1998 | K983510 | CHEMSTRIP 101 URINE ANALYZER Boehringer Mannheim Corp. | KQO |
| Jun 10, 1998 | K980047 | URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER Yeongdong Pharmaceutical Corp. | KQO |
| Aug 25, 1997 | K972141 | THE YELLOW IRIS URINALYSIS WORKSTATION Intl. Remote Imaging Systems | KQO |
| Jul 22, 1996 | K954156 | STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY Solarcare Technologies Corp,Inc. | KQO |
| Jun 21, 1996 | K954514 | UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE Sciteck Diagnostics, Inc. | KQO |
| Jun 12, 1996 | K960546 | CLINITEK 50 URINE CHEMISTRY ANALYZER Bayer Corp. | KQO |
| May 14, 1996 | K951877 | AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE Chimera Research & Chemical, Inc. | KQO |
| Apr 30, 1996 | K954158 | STC DIAGNOSTICS AUTO-LYTE PH ASSAY Solarcare Technologies Corp,Inc. | KQO |
| Mar 22, 1996 | K960054 | 900UDX URINE PATHOLOGY SYSTEM Intl. Remote Imaging Systems | KQO |
| Oct 23, 1995 | K954024 | CHEMSTRIP CRITERION URINE ANALYZER Boehringer Mannheim Corp. | KQO |
| Feb 22, 1995 | K946183 | CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER Heraeus Kulzer, Inc. | KQO |
| Nov 8, 1994 | K943592 | CHEMSTRIP MINI UA URINE ANALYZER Boehringer Mannheim Corp. | KQO |
| Sep 20, 1994 | K943463 | THE YELLOW IRIS Intl. Remote Imaging Systems | KQO |
| Jun 13, 1994 | K935408 | UA PERFECT Chimera Research & Chemical, Inc. | KQO |
| Oct 14, 1993 | K934042 | CHEMSTRIP SUPER UA URINE ANALYZER Boehringer Mannheim Corp. | KQO |
| Aug 19, 1993 | K932674 | CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM Miles Inc., Dental Products | KQO |
| Jun 15, 1993 | K931602 | CHEMSTRIP URINE ANALYZER Boehringer Mannheim Corp. | KQO |
| Jan 28, 1993 | K926359 | CLINITEK 200+ URINE CHEMISTRY ANALYZER Heraeus Kulzer, Inc. | KQO |
| Mar 24, 1992 | K921087 | CHEMSTRIP URINE ANALYZER Boehringer Mannheim Corp. | KQO |
| Mar 6, 1987 | K870526 | SUPER URINE ANALYZER SYSTEM Kyoto Daiichi Kagaku Co., Ltd., JP | KQO |
| Aug 24, 1984 | K841041 | CLINI-TEK AUTO 2000 REFLECTANCE SPECTR Miles Laboratories, Inc. | KQO |
| Aug 15, 1984 | K842237 | CLINITEK 200 SEMI-AUTOMATED URINALYSIS Miles Laboratories, Inc. | KQO |
| Jul 25, 1984 | K842238 | CLINITEK 10 SEMI-AUTO URINALYSIS SYS Miles Laboratories, Inc. | KQO |
| May 1, 1984 | K840996 | URINE ANALYZER SYSTEM Kyoto Diagnostics, Inc. | KQO |
| Jun 17, 1983 | K830220 | YELLOW IRIS TM Intl. Remote Imaging Systems | KQO |
| Jul 6, 1982 | K821738 | CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST Miles Laboratories, Inc. | KQO |
| May 5, 1982 | K813056 | AUTOMATED URINALYSIS SYSTEM Kyoto Daiichi Kagaku Co., Ltd. | KQO |
| Mar 21, 1977 | K761306 | CLINILAB AUTOMATED URINALYSIS SYSTEM Miles Laboratories, Inc. | KQO |
| Oct 29, 1976 | K760472 | INSTRUMENTED SYSTEM FOR URINALYSIS Miles Laboratories, Inc. | KQO |
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