Product code JIL
- Device name
- Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1340
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193514 | AUTION MAX AX-4060 Urinalysis System | Arkray, Inc. | 2023-04-13 |
| K183432 | cobas u 601 urinalysis test system | Roche Diagnostics | 2019-05-07 |
| K173327 | DIP/U.S. Urine Analysis Test System | Healthy.Io, Ltd. | 2018-07-18 |
| K180356 | inui In-Home Urine Analysis Test System | Scanadu, Inc. | 2018-05-25 |
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips | DFI Co., Ltd. | 2018-05-23 |
| K171521 | DUS R-50S (Urine Chemistry system) | DFI Co., Ltd. | 2018-02-16 |
| K171083 | iChemVELOCITY Automated Urine Chemistry System | Iris Diagnostics, A Division of Iris International, Inc. | 2017-05-12 |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | Arkray, Inc. | 2016-10-07 |
| K160372 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | 2016-07-22 |
| K141289 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS | Teco Diagnostics | 2015-07-24 |
| K131600 | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS | Teco Diagnostics | 2014-05-29 |
| K120124 | FORESIGHT U120 URINE ANALYZER | ACON Laboratories, Inc. | 2012-03-06 |
| K101673 | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 | Teco Diagnostics | 2011-02-04 |
| K091216 | CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 | Siemens Healthcare Diagnostics | 2009-10-09 |
| K061812 | COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 | Analyticon Biotechnologies AG | 2007-04-06 |
| K061846 | COMBI SCAN100 | Analyticon Biotechnologies AG | 2007-04-06 |
| K063390 | URINE CHEMISTRY ANALYZER UR-50 | Ind Diagnostic, Inc. | 2007-03-01 |
| K063276 | CLINITEK ADVANTUS, MODEL 1420 | Bayer Healthcare, LLC | 2006-12-28 |
| K061742 | URYXXON RELAX URINE ANALYZER | Macherey-Nagel GmbH & Co. KG | 2006-09-06 |
| K060280 | ICHEM 100 URINE CHEMISTRY ANALYZER | Iris International, Inc. | 2006-06-13 |
| K052525 | CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS | DFI Co., Ltd. | 2006-03-29 |
| K051034 | URYXXON 200 URINE ANALYZER | Macherey-Nagel GmbH & Co. KG | 2005-11-22 |
| K050801 | URISCAN OPTIMA II URINE ANALYZER | Yd Diagnostics | 2005-04-20 |
| K042641 | CHEMVIEW-10 | Cenogenics Corp. | 2005-01-07 |
| K033851 | DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) | Hypoguard USA, Inc. | 2004-03-02 |
| K023885 | COMBI-SCREEN, MODELS 10SL AND 11SL | Analyticon Biotechnologies AG | 2003-10-21 |
| K032437 | CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS | Roche Diagnostics Corp. | 2003-10-08 |
| K022386 | POCKETCHEM UA AUTION STICKS 10TA | Arkray, Inc. | 2002-09-17 |
| K020175 | URS-IG (GLUCOSE TEST) | Teco Diagnostics | 2002-03-21 |
| K012397 | URISYS 2400 URINE TEST STRIP | Roche Diagnostics Corp. | 2001-09-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08806141302209 | Just Fitter 10 Parameter Test Strips | DFI CO.,LTD | 2020-09-22 |
| 08806141302070 | CYBOW 10 | DFI CO.,LTD | 2020-06-29 |
| 10301932883509 | KETO-DIASTIX® | ASCENSIA DIABETES CARE US INC. | 2019-06-06 |
| 10301932882212 | KETO-DIASTIX® | ASCENSIA DIABETES CARE US INC. | 2019-06-06 |
| 08806141301479 | QTEST™ 11 | DFI CO.,LTD | 2018-12-21 |
| 08806125680279 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 08806125680286 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 10673486000382 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 10673486000337 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 10673486000344 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 10673486000351 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 10673486000368 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 10673486000375 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 08806125680217 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-12-21 |
| 10612479183466 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479197463 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183527 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183497 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10607415002062 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10607415002055 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10607415001294 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 08806141300755 | CYBOW 11 | DFI CO.,LTD | 2016-10-06 |
| 10673486000238 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-10-04 |
| 10673486000290 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-10-04 |
| 10673486000306 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-10-04 |
| 10673486000313 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-10-04 |
| 10673486000320 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-10-03 |
| 10301932806508 | DIASTIX® | ASCENSIA DIABETES CARE US INC. | 2016-09-16 |
| 10301932803217 | DIASTIX® | ASCENSIA DIABETES CARE US INC. | 2016-09-16 |
| 08806125680231 | URiSCAN 10 ACR strip | YD Diagnostics CORP. | 2016-08-05 |