FDA 510(k) Applications for Medical Device Product Code "JIL"
(Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
| 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 |
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