CJY — Azo Dye, Calcium Class II
FDA product code CJY covers "Azo Dye, Calcium", a Class II medical device regulated under 21 CFR 862.1145. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K244042 | abbott ireland | Calcium2 | February 10, 2025 |
| K191396 | horiba abx | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | July 26, 2019 |
| K182042 | randox laboratories | Randox Calcium (Ca) | October 23, 2018 |
| K151113 | elitechgroup | ELITech Clinical Systems CALCIUM ARSENAZO | July 22, 2015 |
| K123171 | horiba abx | ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX | July 3, 2013 |
| K120626 | vital diagnostics (manufacturing) ptyltd | EON CALCIUM REGENT | August 22, 2012 |
| K083386 | siemens healthcare diagnostics | ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 0 | April 2, 2009 |
| K072356 | alfa wassermann diagnostic technologies | S-TEST CA | June 24, 2008 |
| K073355 | thermofisher scientific | CALCIUM, SCAL, NORTROL, ABTROL | February 28, 2008 |
| K072443 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY | September 24, 2007 |
| K072440 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL | September 20, 2007 |
| K062855 | abbott laboratories | CALCIUM | November 22, 2006 |
| K061575 | olympus america | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 | October 5, 2006 |
| K051757 | diagnostic chemicals | CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 | November 10, 2005 |
| K040972 | genchem | CALCIUM, AZO DYE REAGENT | December 27, 2004 |
| K021334 | wiener laboratories saic | WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB. | September 10, 2002 |
| K022049 | hemagen diagnostics | MODIFICATION TO RAICHEM CALCIUM REAGENT | July 19, 2002 |
| K011441 | jas diagnostics | JAS CALCIUM (ARSENAZO) REAGENT | July 9, 2001 |
| K983789 | careside | CARESIDE CALCIUM, ORIGINAL | December 17, 1998 |
| K981794 | hichem diagnostics | HICHEM CALCIUM REAGENT KIT | July 29, 1998 |