FDA 510(k) Applications for Medical Device Product Code "CJY"
(Azo Dye, Calcium)

FDA 510(k) Number Applicant Device Name Decision Date
K981578 ABBOTT LABORATORIES CA 06/16/1998
K062855 ABBOTT LABORATORIES CALCIUM 11/22/2006
K981232 ABBOTT MFG., INC. CA 05/18/1998
K880949 ADVANCED BIOMEDICAL METHODS, INC. SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER 04/05/1988
K072356 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. S-TEST CA 06/24/2008
K902476 AMRESCO, INC. CALCIUM:ARSENAZO III 07/17/1990
K891061 BIOTROL, USA, INC. BIOTROL CALCIUM MONOREACTIF 08/10/1989
K983789 CARESIDE, INC. CARESIDE CALCIUM, ORIGINAL 12/17/1998
K894476 CATACHEM, INC. CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION 10/12/1989
K900231 COULTER CORP. COULTER CALCIUM REAGENT 04/03/1990
K890302 DATA MEDICAL ASSOCIATES, INC. CALCIUM PLUS PROCEDURE 02/27/1989
K944255 DATA MEDICAL ASSOCIATES, INC. DMA CALCIUM PLUS PROCEDURE 12/06/1994
K051757 DIAGNOSTIC CHEMICALS LTD. CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 11/10/2005
K895873 DIAGNOSTIC CHEMICALS, LTD. (USA) CALCIUM, CATALOGUE NUMBER140-20 12/12/1989
K151113 ELITechGroup ELITech Clinical Systems CALCIUM ARSENAZO 07/22/2015
K040972 GENCHEM, INC. CALCIUM, AZO DYE REAGENT 12/27/2004
K761029 HARLECO AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL 11/30/1976
K771928 HARLECO CALCIUM SET, ITEM NO. 65004 11/14/1977
K813040 HARLECO ULTRACHEM CA, ITEM #64975 11/10/1981
K770817 HARLECO ULTRACHEM CALCIUM 07/11/1977
K022049 HEMAGEN DIAGNOSTICS, INC. MODIFICATION TO RAICHEM CALCIUM REAGENT 07/19/2002
K941764 HI CHEM, INC. HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 05/13/1994
K890584 HICHEM DIAGNOSTICS HI CHEM CALCIUM REAGENT #88808 04/10/1989
K981794 HICHEM DIAGNOSTICS HICHEM CALCIUM REAGENT KIT 07/29/1998
K123171 HORIBA ABX S.A.S. ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT 07/03/2013
K011441 JAS Diagnostics, Inc. JAS CALCIUM (ARSENAZO) REAGENT 07/09/2001
K961226 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE 05/07/1996
K922835 KING DIAGNOSTICS, INC. CALCIUM (AZ III) REAGENT 08/04/1992
K061575 OLYMPUS AMERICA, INC. OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 10/05/2006
K982035 OLYMPUS DIAGNOSTICA GMBH OLYMPUS CALCIUM ARSENAZO III REAGENT 06/24/1998
K072443 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY 09/24/2007
K072440 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) 09/20/2007
K974607 RANDOX LABORATORIES, LTD. RANDOX CALCIUM 02/02/1998
K880576 REAGENTS APPLICATIONS, INC. RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID) 06/10/1988
K883453 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE REAGENT FOR CALCIUM 10/25/1988
K083386 SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) 04/02/2009
K933678 SIGMA CHEMICAL CO. SIGMA CALCIUM REAGENT 03/11/1994
K894204 SIGMA DIAGNOSTICS, INC. CALCIUM (ARSENAZO III) REAGENT 10/04/1989
K963536 SIGMA DIAGNOSTICS, INC. SIGMA DIAGNOSTICS CALICIUM REAGENT 10/10/1996
K953395 SYNERMED, INC. SYNERMED CALCIUM REAGENT KIT 08/31/1995
K880242 THE RUPP & BOWMAN CO. KONE CALCIUM TEST 03/15/1988
K073355 THERMO FISHER SCIENTIFIC OY CALCIUM, SCAL, NORTROL, ABTROL 02/28/2008
K120626 VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD EON CALCIUM REGENT 08/22/2012
K021334 WIENER LABORATORIES S.A.I.C. WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5 09/10/2002


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