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