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JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Class I

FDA Device Classification

Classification Details

Product Code
JJE
Device Class
Class I
Regulation Number
862.2160
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K183375horibaYumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, February 12, 2019
K133519carolina liquid chemistriesCAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISMay 16, 2014
K130915jas diagnosticsXL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACKMay 15, 2014
K131554randox laboratoriesRX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (January 9, 2014
K130276siemens healthcare diagnosticsDIMENSION EXL WITH LM SYSTEMMarch 22, 2013
K113253alfa wassermann diagnostic technologiesACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENMay 17, 2012
K112999siemens healthcare diagnosticsDIMENSION CLINICAL CHEMISTRY SYSTEMNovember 22, 2011
K110035thermofisher scientificINDIKOJune 28, 2011
K073370teco diagnosticsTC MATRIX CLINICAL CHEMISTRY ANALYZERMay 8, 2008
K063144ortho-clinical diagnosticsVITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEMNovember 13, 2006
K051087dade behringDIMENSION VISTA INTEGRATED SYSTEMJuly 11, 2005
K042169stanbio laboratorySTANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERMarch 14, 2005
K040958tokyo boeki medical systemPRESTIGE MODELS 24I AND 400 AND MGC MODEL 240February 15, 2005
K023764beckman coulterUNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100January 28, 2003
K010500lab-interlinkAUTOMATED WORKCELL CONTROL SOFTWAREAugust 1, 2001
K003721olympus americaMODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZERDecember 18, 2000
K002982olympus americaOLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZEROctober 25, 2000
K983345bayerBAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORYDecember 7, 1998
K974779abbott laboratoriesABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZERFebruary 13, 1998
K974651abbott laboratoriesABBOTT AXSYM SYSTEMFebruary 12, 1998