FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K120124 |
ACON LABORATORIES, INC. |
FORESIGHT U120 URINE ANALYZER |
03/06/2012 |
K973142 |
AMERITEK, INC. |
DBEST REAGENT STRIP FOR URINALYSIS |
10/20/1997 |
K061812 |
ANALYTICON BIOTECHNOLOGIES AG |
COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 |
04/06/2007 |
K061846 |
ANALYTICON BIOTECHNOLOGIES AG |
COMBI SCAN100 |
04/06/2007 |
K023885 |
ANALYTICON BIOTECHNOLOGIES AG |
COMBI-SCREEN, MODELS 10SL AND 11SL |
10/21/2003 |
K193514 |
Arkray Inc. |
AUTION MAX AX-4060 Urinalysis System |
04/13/2023 |
K160062 |
ARKRAY, Inc. |
AUTION ELEVEN Semi-Automated Urinalysis System |
10/07/2016 |
K022386 |
ARKRAY, INC. |
POCKETCHEM UA AUTION STICKS 10TA |
09/17/2002 |
K063276 |
BAYER HEALTHCARE, LLC |
CLINITEK ADVANTUS, MODEL 1420 |
12/28/2006 |
K042641 |
CENOGENICS CORP. |
CHEMVIEW-10 |
01/07/2005 |
K052525 |
D.F.I. CO LTD |
CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS |
03/29/2006 |
K181024 |
DFI Co., Ltd. |
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips |
05/23/2018 |
K171521 |
DFI Co., Ltd. |
DUS R-50S (Urine Chemistry system) |
02/16/2018 |
K961375 |
GENESIS LABS, INC. |
DIA SCREEN 10 WAY REAGENT STRIPS |
06/18/1996 |
K173327 |
Healthy.io Ltd |
DIP/U.S. Urine Analysis Test System |
07/18/2018 |
K010973 |
HYPOGUARD USA, INC. |
DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 |
09/11/2001 |
K033851 |
HYPOGUARD USA, INC. |
DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) |
03/02/2004 |
K063390 |
IND DIAGNOSTIC INC. |
URINE CHEMISTRY ANALYZER UR-50 |
03/01/2007 |
K171083 |
Iris Diagnostics, a Division of Iris International Inc |
iChemVELOCITY Automated Urine Chemistry System |
05/12/2017 |
K060280 |
IRIS INTERNATIONAL, INC. |
ICHEM 100 URINE CHEMISTRY ANALYZER |
06/13/2006 |
K051034 |
MACHEREY-NAGEL GMBH & CO., KG. |
URYXXON 200 URINE ANALYZER |
11/22/2005 |
K061742 |
MACHEREY-NAGEL GMBH & CO., KG. |
URYXXON RELAX URINE ANALYZER |
09/06/2006 |
K991927 |
MACHEREY-NAGEL-DUREN |
MEDI-TEST COMBI 11 |
09/17/1999 |
K953661 |
POLYMER TECHNOLOGY INTL. |
FIRST CHOICE GLUCOSE URINE TEST STRIPS |
06/14/1996 |
K183432 |
Roche Diagnostics |
cobas u 601 urinalysis test system |
05/07/2019 |
K032437 |
ROCHE DIAGNOSTICS CORP. |
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS |
10/08/2003 |
K012397 |
ROCHE DIAGNOSTICS CORP. |
URISYS 2400 URINE TEST STRIP |
09/26/2001 |
K180356 |
Scanadu, Inc. |
inui In-Home Urine Analysis Test System |
05/25/2018 |
K091216 |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 |
10/09/2009 |
K954968 |
TCPI, INC. |
HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST |
07/26/1996 |
K970250 |
TECO DIAGNOSTICS |
CLINISTRIP |
04/08/1997 |
K141289 |
TECO DIAGNOSTICS |
TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS |
07/24/2015 |
K101673 |
TECO DIAGNOSTICS |
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 |
02/04/2011 |
K131600 |
TECO DIAGNOSTICS |
URS-2GP (GLUCOSE PROTEIN) URINE STRIPS |
05/29/2014 |
K020175 |
TECO DIAGNOSTICS |
URS-IG (GLUCOSE TEST) |
03/21/2002 |
K160372 |
TECO DIAGNOSTICS, INC. |
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM |
07/22/2016 |
K050801 |
YD DIAGNOSTICS |
URISCAN OPTIMA II URINE ANALYZER |
04/20/2005 |