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JFY — Enzymatic Method, Creatinine Class II

FDA Device Classification

Classification Details

Product Code
JFY
Device Class
Class II
Regulation Number
862.1225
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252619qstagQSCHECK UISACRFebruary 20, 2026
K212223siemens healthcare diagnosticsAtellica CH Enzymatic Creatinine_3 (ECre3)November 24, 2021
K193649horiba abxYumizen C1200 Creatinine PAPMay 10, 2021
K182384healthy.ioACR LAB Urine Analysis Test SystemJuly 26, 2019
K183555instrumentation laboratoryGEM Premier ChemSTATFebruary 16, 2019
K182038yd diagnostics corporationURiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerDecember 10, 2018
K182063ortho-clinical diagnosticsVITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VIOctober 30, 2018
K161527teco diagnosticsTeco Creatinine Enzymatic Reagent KitJuly 21, 2017
K152835teco diagnosticsURITEK TC-201 URINE CHEMISTRY TEST SYSTEMMarch 7, 2016
K142391acon laboratoriesMission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( MicroalbuDecember 22, 2014
K132399elitechgroupELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, January 3, 2014
K103376seppimELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTNovember 18, 2011
K110137horiba abxABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AAugust 10, 2011
K093458beckman coulterSYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298December 4, 2009
K091742beckman coulterSYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298August 14, 2009
K090330siemens healthcare diagnosticsDIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATMay 22, 2009
K080073alfa wassermannS-TEST CREATININE (CRE)June 30, 2008
K073634sentinel chMULTIGENT CREATININE (ENZYMATIC) ASSAYJune 19, 2008
K072409axis-shield pocAFINION ACR AND ACR CONTROLFebruary 12, 2008
K073055dade behringDIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270January 3, 2008