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 |
| K072356 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. | S-TEST CA | 06/24/2008 |
| K983789 | CARESIDE, INC. | CARESIDE CALCIUM, ORIGINAL | 12/17/1998 |
| K051757 | DIAGNOSTIC CHEMICALS LTD. | CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 | 11/10/2005 |
| K151113 | ELITechGroup | ELITech Clinical Systems CALCIUM ARSENAZO | 07/22/2015 |
| K040972 | GENCHEM, INC. | CALCIUM, AZO DYE REAGENT | 12/27/2004 |
| K022049 | HEMAGEN DIAGNOSTICS, INC. | MODIFICATION TO RAICHEM CALCIUM REAGENT | 07/19/2002 |
| 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 |
| K191396 | Horiba ABX SAS | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | 07/26/2019 |
| 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 |
| 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 |
| K182042 | Randox Laboratories Ltd. | Randox Calcium (Ca) | 10/23/2018 |
| K974607 | RANDOX LABORATORIES, LTD. | RANDOX CALCIUM | 02/02/1998 |
| 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 |
| K963536 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS CALICIUM REAGENT | 10/10/1996 |
| 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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