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CJY — Azo Dye, Calcium Class II

FDA Device Classification

Classification Details

Product Code
CJY
Device Class
Class II
Regulation Number
862.1145
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K244042abbott irelandCalcium2February 10, 2025
K191396horiba abxYumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeJuly 26, 2019
K182042randox laboratoriesRandox Calcium (Ca)October 23, 2018
K151113elitechgroupELITech Clinical Systems CALCIUM ARSENAZOJuly 22, 2015
K123171horiba abxABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABXJuly 3, 2013
K120626vital diagnostics (manufacturing) ptyltdEON CALCIUM REGENTAugust 22, 2012
K083386siemens healthcare diagnosticsADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 0April 2, 2009
K072356alfa wassermann diagnostic technologiesS-TEST CAJune 24, 2008
K073355thermofisher scientificCALCIUM, SCAL, NORTROL, ABTROLFebruary 28, 2008
K072443ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAYSeptember 24, 2007
K072440ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODELSeptember 20, 2007
K062855abbott laboratoriesCALCIUMNovember 22, 2006
K061575olympus americaOLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117October 5, 2006
K051757diagnostic chemicalsCALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91November 10, 2005
K040972genchemCALCIUM, AZO DYE REAGENTDecember 27, 2004
K021334wiener laboratories saicWIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.September 10, 2002
K022049hemagen diagnosticsMODIFICATION TO RAICHEM CALCIUM REAGENTJuly 19, 2002
K011441jas diagnosticsJAS CALCIUM (ARSENAZO) REAGENTJuly 9, 2001
K983789caresideCARESIDE CALCIUM, ORIGINALDecember 17, 1998
K981794hichem diagnosticsHICHEM CALCIUM REAGENT KITJuly 29, 1998