Home / Device Classification / JIL

JIL — Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K193514arkrayAUTION MAX AX-4060 Urinalysis SystemApril 13, 2023
K183432roche diagnosticscobas u 601 urinalysis test systemMay 7, 2019
K173327healthy.ioDIP/U.S. Urine Analysis Test SystemJuly 18, 2018
K180356scanaduinui In-Home Urine Analysis Test SystemMay 25, 2018
K181024dfi coDUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsMay 23, 2018
K171521dfi coDUS R-50S (Urine Chemistry system)February 16, 2018
K171083iris diagnostics, a division of iris internationaliChemVELOCITY Automated Urine Chemistry SystemMay 12, 2017
K160062arkrayAUTION ELEVEN Semi-Automated Urinalysis SystemOctober 7, 2016
K160372teco diagnosticsURITEK TC-201 URINE CHEMISTRY TEST SYSTEMJuly 22, 2016
K141289teco diagnosticsTC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPSJuly 24, 2015
K131600teco diagnosticsURS-2GP (GLUCOSE PROTEIN) URINE STRIPSMay 29, 2014
K120124acon laboratoriesFORESIGHT U120 URINE ANALYZERMarch 6, 2012
K101673teco diagnosticsURITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10February 4, 2011
K091216siemens healthcare diagnosticsCLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797October 9, 2009
K061812analyticon biotechnologiesCOMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005April 6, 2007
K061846analyticon biotechnologiesCOMBI SCAN100April 6, 2007
K063390ind diagnosticURINE CHEMISTRY ANALYZER UR-50March 1, 2007
K063276bayer healthcareCLINITEK ADVANTUS, MODEL 1420December 28, 2006
K061742macherey-nagel gmbh and co. kgURYXXON RELAX URINE ANALYZERSeptember 6, 2006
K060280iris internationalICHEM 100 URINE CHEMISTRY ANALYZERJune 13, 2006