JIL — Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Class II
FDA product code JIL covers "Method, Enzymatic, Glucose (Urinary, Non-Quantitative)", a Class II medical device regulated under 21 CFR 862.1340. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JIL
- Device Class
- Class II
- Regulation Number
- 862.1340
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K193514 | arkray | AUTION MAX AX-4060 Urinalysis System | April 13, 2023 |
| K183432 | roche diagnostics | cobas u 601 urinalysis test system | May 7, 2019 |
| K173327 | healthy.io | DIP/U.S. Urine Analysis Test System | July 18, 2018 |
| K180356 | scanadu | inui In-Home Urine Analysis Test System | May 25, 2018 |
| K181024 | dfi co | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips | May 23, 2018 |
| K171521 | dfi co | DUS R-50S (Urine Chemistry system) | February 16, 2018 |
| K171083 | iris diagnostics, a division of iris international | iChemVELOCITY Automated Urine Chemistry System | May 12, 2017 |
| K160062 | arkray | AUTION ELEVEN Semi-Automated Urinalysis System | October 7, 2016 |
| K160372 | teco diagnostics | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | July 22, 2016 |
| K141289 | teco diagnostics | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS | July 24, 2015 |
| K131600 | teco diagnostics | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS | May 29, 2014 |
| K120124 | acon laboratories | FORESIGHT U120 URINE ANALYZER | March 6, 2012 |
| K101673 | teco diagnostics | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 | February 4, 2011 |
| K091216 | siemens healthcare diagnostics | CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 | October 9, 2009 |
| K061846 | analyticon biotechnologies | COMBI SCAN100 | April 6, 2007 |
| K061812 | analyticon biotechnologies | COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 | April 6, 2007 |
| K063390 | ind diagnostic | URINE CHEMISTRY ANALYZER UR-50 | March 1, 2007 |
| K063276 | bayer healthcare | CLINITEK ADVANTUS, MODEL 1420 | December 28, 2006 |
| K061742 | macherey-nagel gmbh and co. kg | URYXXON RELAX URINE ANALYZER | September 6, 2006 |
| K060280 | iris international | ICHEM 100 URINE CHEMISTRY ANALYZER | June 13, 2006 |