FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K070929 |
ACON LABORATORIES, INC. |
ACON U120 URINE ANALYZER, MODEL U111-101 |
07/30/2007 |
K142543 |
ACON LABORATORIES, INC. |
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control |
05/11/2015 |
K091472 |
ARJ MEDICAL, INC. |
URITEST 50 AND URITEST 500 URINE ANALYZER |
04/27/2010 |
K121456 |
ARKRAY, INC. |
AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL |
02/01/2013 |
K093098 |
ARKRAY, INC. |
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM |
12/23/2009 |
K960546 |
BAYER CORP. |
CLINITEK 50 URINE CHEMISTRY ANALYZER |
06/12/1996 |
K031947 |
BAYER HEALTHCARE, LLC |
BAYER CLINITEK STATUS ANALYZER |
12/19/2003 |
K012829 |
BIOCARE CORP. |
STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS |
11/02/2001 |
K983510 |
BOEHRINGER MANNHEIM CORP. |
CHEMSTRIP 101 URINE ANALYZER |
10/27/1998 |
K951877 |
CHIMERA RESEARCH & CHEMICAL, INC. |
AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE |
05/14/1996 |
K954514 |
CHIMERA RESEARCH & CHEMICAL, INC. |
UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE |
06/21/1996 |
K102188 |
DFI CO., LTD. |
CYBOW READER, MODELS 300 & 720 |
08/09/2011 |
K053253 |
HEMOCUE AB |
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM |
02/17/2006 |
K030600 |
INTERNATIONAL REMOTE IMAGING SYSTEMS |
AUTION JET AJ-4270 URINE ANALYZER |
07/11/2003 |
K013783 |
INTERNATIONAL REMOTE IMAGING SYSTEMS |
AUTION MAX AX-4280 URINALYSIS SYSTEM |
01/18/2002 |
K960054 |
INTL. REMOTE IMAGING SYSTEMS |
900UDX URINE PATHOLOGY SYSTEM |
03/22/1996 |
K972141 |
INTL. REMOTE IMAGING SYSTEMS |
THE YELLOW IRIS URINALYSIS WORKSTATION |
08/25/1997 |
K101852 |
IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I |
CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT |
03/23/2011 |
K093555 |
Roche Diagnostics |
COBAS U411 TEST SYSTEM |
04/02/2010 |
K140717 |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT |
11/17/2014 |
K954158 |
SOLARCARE TECHNOLOGIES CORP,INC. |
STC DIAGNOSTICS AUTO-LYTE PH ASSAY |
04/30/1996 |
K954156 |
SOLARCARE TECHNOLOGIES CORP,INC. |
STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY |
07/22/1996 |
K042421 |
TECO DIAGNOSTICS |
URITEK 151 URINE ANALYZER, MODEL TC-151 |
05/09/2005 |
K051526 |
TECO DIAGNOSTICS |
URITEK-720+ URINE ANALYZER |
08/16/2005 |
K141874 |
YD DIAGNOSTICS CORP. |
URISCAN OPTIMA |
05/28/2015 |
K980047 |
YEONGDONG PHARMACEUTICAL CORP. |
URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER |
06/10/1998 |