Product code CJY
- Device name
- Azo Dye, Calcium
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1145
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K244042 | Calcium2 | Abbott Ireland | 2025-02-10 |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | HORIBA ABX SAS | 2019-07-26 |
| K182042 | Randox Calcium (Ca) | Randox Laboratories, Ltd. | 2018-10-23 |
| K151113 | ELITech Clinical Systems CALCIUM ARSENAZO | Elitechgroup | 2015-07-22 |
| K123171 | ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT | HORIBA ABX SAS | 2013-07-03 |
| K120626 | EON CALCIUM REGENT | Vital Diagnostics (Manufacturing) Ptyltd | 2012-08-22 |
| K083386 | ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) | Siemens Healthcare Diagnostics | 2009-04-02 |
| K072356 | S-TEST CA | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 |
| K073355 | CALCIUM, SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | 2008-02-28 |
| K072443 | VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY | Ortho-Clinical Diagnostics, Inc. | 2007-09-24 |
| K072440 | VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) | Ortho-Clinical Diagnostics, Inc. | 2007-09-20 |
| K062855 | CALCIUM | Abbott Laboratories | 2006-11-22 |
| K061575 | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 | Olympus America, Inc. | 2006-10-05 |
| K051757 | CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 | Diagnostic Chemicals , Ltd. | 2005-11-10 |
| K040972 | CALCIUM, AZO DYE REAGENT | Genchem, Inc. | 2004-12-27 |
| K021334 | 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 | Wiener Laboratories Saic | 2002-09-10 |
| K022049 | MODIFICATION TO RAICHEM CALCIUM REAGENT | Hemagen Diagnostics, Inc. | 2002-07-19 |
| K011441 | JAS CALCIUM (ARSENAZO) REAGENT | Jas Diagnostics, Inc. | 2001-07-09 |
| K983789 | CARESIDE CALCIUM, ORIGINAL | Careside, Inc. | 1998-12-17 |
| K981794 | HICHEM CALCIUM REAGENT KIT | Hichem Diagnostics | 1998-07-29 |
| K982035 | OLYMPUS CALCIUM ARSENAZO III REAGENT | Olympus Diagnostica GmbH | 1998-06-24 |
| K981578 | CA | Abbott Laboratories | 1998-06-16 |
| K981232 | CA | Abbott Mfg., Inc. | 1998-05-18 |
| K974607 | RANDOX CALCIUM | Randox Laboratories, Ltd. | 1998-02-02 |
| K963536 | SIGMA DIAGNOSTICS CALICIUM REAGENT | Sigma Diagnostics, Inc. | 1996-10-10 |
| K961226 | EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-07 |
| K953395 | SYNERMED CALCIUM REAGENT KIT | Synermed, Inc. | 1995-08-31 |
| K944255 | DMA CALCIUM PLUS PROCEDURE | Data Medical Associates, Inc. | 1994-12-06 |
| K941764 | HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 | Hi Chem, Inc. | 1994-05-13 |
| K933678 | SIGMA CALCIUM REAGENT | Sigma Chemical Co. | 1994-03-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03610230008607 | Yumizen C1200 Calcium AS | HORIBA ABX SAS | 2020-05-06 |
| 00380740161514 | ARCHITECT | Abbott GmbH | 2020-03-09 |
| 00380740161507 | ARCHITECT | Abbott GmbH | 2020-03-09 |
| 00380740161491 | ARCHITECT | Abbott GmbH | 2020-03-09 |
| 10758750031795 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2019-11-13 |
| 05055273208368 | CALCIUM (Ca) | RANDOX LABORATORIES LIMITED | 2019-06-03 |
| 00386100002060 | Ca Reagent Kit | MEDICA CORPORATION | 2019-02-14 |
| 05060500091835 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2017-02-28 |
| 15099590060183 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 15099590011086 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 15099590000325 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| EABA40000241 | Piccolo Basic Metabolic Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000411 | Piccolo AmLyte 13 | ABAXIS, INC. | 2016-09-23 |
| EABA40000371 | Piccolo MetLac 12 Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000351 | Piccolo BioChemistry Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000311 | Piccolo Basic Metabolic Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000291 | Piccolo General Chemistry 13 | ABAXIS, INC. | 2016-09-23 |
| EABA40000281 | Piccolo Comprehensive Metabolic Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000271 | Piccolo Renal Function Panel | ABAXIS, INC. | 2016-09-23 |
| 05060500090463 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 05060500090470 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 05060500090487 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 05060500090494 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 05060500090500 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 00851445007099 | GENCHEM™Calcium, Azo Dye Reagent | GENCHEM INC | 2016-09-19 |
| 05055273200904 | Ca | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 00845275001082 | Thermo Scientific Infinity™ | Fisher Diagnostics | 2016-09-16 |
| 05055273200881 | Calcium (Ca) | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 10758750009114 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-23 |
| 03610230005750 | ABX PENTRA CALCIUM AS CP | HORIBA ABX SAS | 2016-08-23 |