Product code KQO
- Device name
- Automated Urinalysis System
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2900
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K141874 | URISCAN OPTIMA | Yd Diagnostics Corp. | 2015-05-28 |
| K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control | ACON Laboratories, Inc. | 2015-05-11 |
| K140717 | CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT | Siemens Healthcare Diagnostics | 2014-11-17 |
| K121456 | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL | Arkray, Inc. | 2013-02-01 |
| K102188 | CYBOW READER, MODELS 300 & 720 | DFI Co., Ltd. | 2011-08-09 |
| K101852 | CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT | Iris International Inc., A Division of Iris Iris I | 2011-03-23 |
| K091472 | URITEST 50 AND URITEST 500 URINE ANALYZER | Arj Medical, Inc. | 2010-04-27 |
| K093555 | COBAS U411 TEST SYSTEM | Roche Diagnostics | 2010-04-02 |
| K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM | Arkray, Inc. | 2009-12-23 |
| K070929 | ACON U120 URINE ANALYZER, MODEL U111-101 | ACON Laboratories, Inc. | 2007-07-30 |
| K053253 | HEMOCUE ALBUMIN 201 ANALYZING SYSTEM | Hemocue AB | 2006-02-17 |
| K051526 | URITEK-720+ URINE ANALYZER | Teco Diagnostics | 2005-08-16 |
| K042421 | URITEK 151 URINE ANALYZER, MODEL TC-151 | Teco Diagnostics | 2005-05-09 |
| K031947 | BAYER CLINITEK STATUS ANALYZER | Bayer Healthcare, LLC | 2003-12-19 |
| K030600 | AUTION JET AJ-4270 URINE ANALYZER | International Remote Imaging Systems | 2003-07-11 |
| K013783 | AUTION MAX AX-4280 URINALYSIS SYSTEM | International Remote Imaging Systems | 2002-01-18 |
| K012829 | STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS | Biocare Corp. | 2001-11-02 |
| K983510 | CHEMSTRIP 101 URINE ANALYZER | Boehringer Mannheim Corp. | 1998-10-27 |
| K980047 | URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER | Yeongdong Pharmaceutical Corp. | 1998-06-10 |
| K972141 | THE YELLOW IRIS URINALYSIS WORKSTATION | Intl. Remote Imaging Systems | 1997-08-25 |
| K954156 | STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY | Solarcare Technologies Corp,Inc. | 1996-07-22 |
| K954514 | UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE | Sciteck Diagnostics, Inc. | 1996-06-21 |
| K960546 | CLINITEK 50 URINE CHEMISTRY ANALYZER | Bayer Corp. | 1996-06-12 |
| K951877 | AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE | Chimera Research & Chemical, Inc. | 1996-05-14 |
| K954158 | STC DIAGNOSTICS AUTO-LYTE PH ASSAY | Solarcare Technologies Corp,Inc. | 1996-04-30 |
| K960054 | 900UDX URINE PATHOLOGY SYSTEM | Intl. Remote Imaging Systems | 1996-03-22 |
| K954024 | CHEMSTRIP CRITERION URINE ANALYZER | Boehringer Mannheim Corp. | 1995-10-23 |
| K946183 | CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER | Heraeus Kulzer, Inc. | 1995-02-22 |
| K943592 | CHEMSTRIP MINI UA URINE ANALYZER | Boehringer Mannheim Corp. | 1994-11-08 |
| K943463 | THE YELLOW IRIS | Intl. Remote Imaging Systems | 1994-09-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06972164410008 | LOOKEE® AscleTrack™ Urine Test Analyzer | Kunming Lianen Biotechnology Co., LTD | 2026-06-26 |
| 06935740751575 | Urine Chemistry Strips | Urit Medical Electronic Co., Ltd. | 2026-06-26 |
| 06935740751568 | Fully-Automated Urine Chemistry Analyzer | Urit Medical Electronic Co., Ltd. | 2026-06-26 |
| 06935740751773 | Urine Strips | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751865 | URINE ANALYZER | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751780 | URINE REAGENT STRIPS | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751858 | Urine Analyzer | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751841 | Urine Analyzer | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751797 | URINE REAGENT STRIPS | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751803 | Urine Strips | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751834 | Urine Strips | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751827 | URINE REAGENT STRIPS | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751810 | Urine Strips | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 04987486005292 | Concentrated Washing Solution 3 | Arkray USA, Inc. | 2024-12-02 |
| 00015482181598 | AUTION EYE™ Calibrator Focus/Calibrator | Arkray USA, Inc. | 2024-12-02 |
| 00015482181574 | AUTION EYE™ Control Solution H/L | Arkray USA, Inc. | 2024-12-02 |
| 00015482181550 | AUTION EYE™ Sheath Solution - 10L Bottle | Arkray USA, Inc. | 2024-12-02 |
| 00015482117344 | AUTION™ Sticks 9EB - Test Strips | Arkray USA, Inc. | 2024-12-02 |
| 00015482790530 | Concentrated Washing Solution 3 | Arkray USA, Inc. | 2019-08-20 |
| 00015482146030 | Aution™ Hybrid AU-4050 Chemical Analyzer | Arkray USA, Inc. | 2017-02-06 |
| 00015482129743 | AUTION™ MAX AX-4022 Analyzer | Arkray USA, Inc. | 2017-02-03 |
| 00015482735265 | AUTION™ Sticks 10EA Test Strips | Arkray USA, Inc. | 2017-02-03 |
| 04987486738114 | AUTION™ Sheath Solution | Arkray USA, Inc. | 2016-09-23 |
| 04987486738107 | AUTION™ Staining Solution BAC | Arkray USA, Inc. | 2016-09-23 |
| 04987486738091 | AUTION™ Staining Solution SED | Arkray USA, Inc. | 2016-09-23 |
| 04987486738084 | AUTION™ Diluent BAC | Arkray USA, Inc. | 2016-09-23 |
| 04987486738077 | AUTION™ Diluent SED | Arkray USA, Inc. | 2016-09-23 |
| 04987486735212 | AUTION™ Uriflet 9HA Test Strips | Arkray USA, Inc. | 2016-09-23 |
| 00015482736279 | AUTION™ Sticks 9EB Test Strips | Arkray USA, Inc. | 2016-09-23 |
| 00015482145057 | AUTION™ MAX AX-4030 Analyzer | Arkray USA, Inc. | 2016-09-23 |