Home / Device Classification / JIX

JIX — Calibrator, Multi-Analyte Mixture Class II

FDA Device Classification

Classification Details

Product Code
JIX
Device Class
Class II
Regulation Number
862.1150
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K161140ortho-clinical diagnosticsVITROS Chemistry Products Calibrator Kit 3May 20, 2016
K153365siemens healthcare diagnosticsADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorDecember 18, 2015
K151552elitechgroupELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech CJuly 8, 2015
K140790siemens healthcare diagnosticsDimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium FJune 15, 2015
K141388beckman coulter irelandSYSTEM CALIBRATERJuly 11, 2014
K133330roche diagnosticsC.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PRNovember 26, 2013
K130765elitechgroupELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CApril 4, 2013
K123321siemens healthcare diagnosticsDIMENSION CHEMISTRY III CALIBRATORYFebruary 15, 2013
K123372abbott laboratoriesABBOTT LIPID MULTI CONSTITUENT CALIBRATORJanuary 14, 2013
K122398siemens healthcare diagnosticsRAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSOctober 12, 2012
K112834verichem laboratoriesMULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KMarch 28, 2012
K112029elitechgroupELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CAugust 30, 2011
K110394vital diagnostics (manufacturing) ptyltdATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)June 9, 2011
K110251beckman coulterSYNCHRON MULTI CALIBRATORMay 25, 2011
K103701siemens healthcare diagnosticsADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORSFebruary 18, 2011
K103171roche diagnosticsELECSYS ANTI-TPO CALSETFebruary 11, 2011
K103403abbott laboratoriesMULTICONSTITUENT CALIBRATORFebruary 4, 2011
K103612siemens healthcare diagnosticsDIMENSION VISA ENZ 2 CALJanuary 25, 2011
K101456roche diagnosticsROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATORSeptember 8, 2010
K101460siemens healthcare diagnosticsLOCI 8 CALIBRATOR, MODEL KC 646July 9, 2010