FDA Product Code
FDA Product Code KQO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2900
510(k) Clearances — 46 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K141874 | URISCAN OPTIMA | Yd Diagnostics Corp. | 2015-05-28 | Traditional | PDF ↗ |
| K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control | ACON Laboratories, Inc. | 2015-05-11 | Traditional | PDF ↗ |
| K140717 | CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT | Siemens Healthcare Diagnostics | 2014-11-17 | Traditional | PDF ↗ |
| K121456 | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL | Arkray, Inc. | 2013-02-01 | Traditional | PDF ↗ |
| K102188 | CYBOW READER, MODELS 300 & 720 | DFI Co., Ltd. | 2011-08-09 | Traditional | PDF ↗ |
| K101852 | CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT | Iris International Inc., A Division of Iris Iris I | 2011-03-23 | Traditional | PDF ↗ |
| K091472 | URITEST 50 AND URITEST 500 URINE ANALYZER | Arj Medical, Inc. | 2010-04-27 | Traditional | PDF ↗ |
| K093555 | COBAS U411 TEST SYSTEM | Roche Diagnostics | 2010-04-02 | Traditional | PDF ↗ |
| K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM | Arkray, Inc. | 2009-12-23 | Special | PDF ↗ |
| K070929 | ACON U120 URINE ANALYZER, MODEL U111-101 | ACON Laboratories, Inc. | 2007-07-30 | Traditional | PDF ↗ |
| K053253 | HEMOCUE ALBUMIN 201 ANALYZING SYSTEM | Hemocue AB | 2006-02-17 | Traditional | PDF ↗ |
| K051526 | URITEK-720+ URINE ANALYZER | Teco Diagnostics | 2005-08-16 | Traditional | PDF ↗ |
| K042421 | URITEK 151 URINE ANALYZER, MODEL TC-151 | Teco Diagnostics | 2005-05-09 | Traditional | PDF ↗ |
| K031947 | BAYER CLINITEK STATUS ANALYZER | Bayer Healthcare, LLC | 2003-12-19 | Traditional | PDF ↗ |
| K030600 | AUTION JET AJ-4270 URINE ANALYZER | International Remote Imaging Systems | 2003-07-11 | Traditional | PDF ↗ |
| K013783 | AUTION MAX AX-4280 URINALYSIS SYSTEM | International Remote Imaging Systems | 2002-01-18 | Traditional | PDF ↗ |
| K012829 | STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS | Biocare Corp. | 2001-11-02 | Traditional | PDF ↗ |
| K983510 | CHEMSTRIP 101 URINE ANALYZER | Boehringer Mannheim Corp. | 1998-10-27 | Special | PDF ↗ |
| K980047 | URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER | Yeongdong Pharmaceutical Corp. | 1998-06-10 | Traditional | PDF ↗ |
| K972141 | THE YELLOW IRIS URINALYSIS WORKSTATION | Intl. Remote Imaging Systems | 1997-08-25 | Traditional | PDF ↗ |
| K954156 | STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY | Solarcare Technologies Corp,Inc. | 1996-07-22 | Traditional | PDF ↗ |
| K954514 | UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE | Sciteck Diagnostics, Inc. | 1996-06-21 | Traditional | PDF ↗ |
| K960546 | CLINITEK 50 URINE CHEMISTRY ANALYZER | Bayer Corp. | 1996-06-12 | Traditional | PDF ↗ |
| K951877 | AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE | Chimera Research & Chemical, Inc. | 1996-05-14 | Traditional | PDF ↗ |
| K954158 | STC DIAGNOSTICS AUTO-LYTE PH ASSAY | Solarcare Technologies Corp,Inc. | 1996-04-30 | Traditional | PDF ↗ |
| K960054 | 900UDX URINE PATHOLOGY SYSTEM | Intl. Remote Imaging Systems | 1996-03-22 | Traditional | PDF ↗ |
| K954024 | CHEMSTRIP CRITERION URINE ANALYZER | Boehringer Mannheim Corp. | 1995-10-23 | Traditional | PDF ↗ |
| K946183 | CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER | Heraeus Kulzer, Inc. | 1995-02-22 | Traditional | PDF ↗ |
| K943592 | CHEMSTRIP MINI UA URINE ANALYZER | Boehringer Mannheim Corp. | 1994-11-08 | Traditional | PDF ↗ |
| K943463 | THE YELLOW IRIS | Intl. Remote Imaging Systems | 1994-09-20 | Traditional | PDF ↗ |
| K935408 | UA PERFECT | Chimera Research & Chemical, Inc. | 1994-06-13 | Traditional | PDF ↗ |
| K934042 | CHEMSTRIP SUPER UA URINE ANALYZER | Boehringer Mannheim Corp. | 1993-10-14 | Traditional | PDF ↗ |
| K932674 | CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM | Miles Inc., Dental Products | 1993-08-19 | Traditional | PDF ↗ |
| K931602 | CHEMSTRIP URINE ANALYZER | Boehringer Mannheim Corp. | 1993-06-15 | Traditional | PDF ↗ |
| K926359 | CLINITEK 200+ URINE CHEMISTRY ANALYZER | Heraeus Kulzer, Inc. | 1993-01-28 | Traditional | PDF ↗ |
| K921087 | CHEMSTRIP URINE ANALYZER | Boehringer Mannheim Corp. | 1992-03-24 | Traditional | PDF ↗ |
| K870526 | SUPER URINE ANALYZER SYSTEM | Kyoto Daiichi Kagaku Co., Ltd. | 1987-03-06 | Traditional | PDF ↗ |
| K841041 | CLINI-TEK AUTO 2000 REFLECTANCE SPECTR | Miles Laboratories, Inc. | 1984-08-24 | Traditional | PDF ↗ |
| K842237 | CLINITEK 200 SEMI-AUTOMATED URINALYSIS | Miles Laboratories, Inc. | 1984-08-15 | Traditional | PDF ↗ |
| K842238 | CLINITEK 10 SEMI-AUTO URINALYSIS SYS | Miles Laboratories, Inc. | 1984-07-25 | Traditional | PDF ↗ |
| K840996 | URINE ANALYZER SYSTEM | Kyoto Diagnostics, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K830220 | YELLOW IRIS TM | Intl. Remote Imaging Systems | 1983-06-17 | Traditional | PDF ↗ |
| K821738 | CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST | Miles Laboratories, Inc. | 1982-07-06 | Traditional | PDF ↗ |
| K813056 | AUTOMATED URINALYSIS SYSTEM | Kyoto Daiichi Kagaku Co., Ltd. | 1982-05-05 | Traditional | PDF ↗ |
| K761306 | CLINILAB AUTOMATED URINALYSIS SYSTEM | Miles Laboratories, Inc. | 1977-03-21 | Traditional | PDF ↗ |
| K760472 | INSTRUMENTED SYSTEM FOR URINALYSIS | Miles Laboratories, Inc. | 1976-10-29 | Traditional | PDF ↗ |
Product code KQO · Class I · Clinical Chemistry. Data: openFDA.