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KQO — Automated Urinalysis System Class I

FDA Device Classification

Classification Details

Product Code
KQO
Device Class
Class I
Regulation Number
862.2900
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K141874yd diagnosticsURISCAN OPTIMAMay 28, 2015
K142543acon laboratoriesMission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission LiquidMay 11, 2015
K140717siemens healthcare diagnosticsCLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALINovember 17, 2014
K121456arkrayAUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET February 1, 2013
K102188dfi coCYBOW READER, MODELS 300 & 720August 9, 2011
K101852iris international inc., a division of iris iris iCHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KITMarch 23, 2011
K091472arj medicalURITEST 50 AND URITEST 500 URINE ANALYZERApril 27, 2010
K093555roche diagnosticsCOBAS U411 TEST SYSTEMApril 2, 2010
K093098arkrayAUTION MAX MODEL AX-4030 URINALYSIS SYSTEMDecember 23, 2009
K070929acon laboratoriesACON U120 URINE ANALYZER, MODEL U111-101July 30, 2007
K053253hemocueHEMOCUE ALBUMIN 201 ANALYZING SYSTEMFebruary 17, 2006
K051526teco diagnosticsURITEK-720+ URINE ANALYZERAugust 16, 2005
K042421teco diagnosticsURITEK 151 URINE ANALYZER, MODEL TC-151May 9, 2005
K031947bayer healthcareBAYER CLINITEK STATUS ANALYZERDecember 19, 2003
K030600international remote imaging systemsAUTION JET AJ-4270 URINE ANALYZERJuly 11, 2003
K013783international remote imaging systemsAUTION MAX AX-4280 URINALYSIS SYSTEMJanuary 18, 2002
K012829biocareSTRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSISNovember 2, 2001
K983510boehringer mannheimCHEMSTRIP 101 URINE ANALYZEROctober 27, 1998
K980047yeongdong pharmaceuticalURISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZERJune 10, 1998
K972141intl. remote imaging systemsTHE YELLOW IRIS URINALYSIS WORKSTATIONAugust 25, 1997