CJY · Azo Dye, Calcium
Clinical Chemistry · 21 CFR 862.1145 · Class 2
Overview
| Product Code | CJY |
|---|---|
| Device Name | Azo Dye, Calcium |
| Regulation | 21 CFR 862.1145 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Classification Rationale
Class II.
Recent Cleared Devices (20 of 47)
Showing 20 most recent of 47 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K244042 | Calcium2 | Abbott Ireland | Feb 10, 2025 | SESE |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | HORIBA ABX SAS | Jul 26, 2019 | SESE |
| K182042 | Randox Calcium (Ca) | Randox Laboratories, Ltd. | Oct 23, 2018 | SESE |
| K151113 | ELITech Clinical Systems CALCIUM ARSENAZO | Elitechgroup | Jul 22, 2015 | SESE |
| 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 | Jul 3, 2013 | SESE |
| K120626 | EON CALCIUM REGENT | Vital Diagnostics (Manufacturing) Ptyltd | Aug 22, 2012 | SESE |
| K083386 | ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) | Siemens Healthcare Diagnostics | Apr 2, 2009 | SESE |
| K072356 | S-TEST CA | Alfa Wassermann Diagnostic Technologies, Inc. | Jun 24, 2008 | SESE |
| K073355 | CALCIUM, SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | Feb 28, 2008 | SESE |
| K072443 | VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY | Ortho-Clinical Diagnostics, Inc. | Sep 24, 2007 | SESE |
| K072440 | VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208) | Ortho-Clinical Diagnostics, Inc. | Sep 20, 2007 | SESE |
| K062855 | CALCIUM | Abbott Laboratories | Nov 22, 2006 | SESE |
| K061575 | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 | Olympus America, Inc. | Oct 5, 2006 | SESE |
| K051757 | CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 | Diagnostic Chemicals , Ltd. | Nov 10, 2005 | SESE |
| K040972 | CALCIUM, AZO DYE REAGENT | Genchem, Inc. | Dec 27, 2004 | SESE |
| 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 | Sep 10, 2002 | SESE |
| K022049 | MODIFICATION TO RAICHEM CALCIUM REAGENT | Hemagen Diagnostics, Inc. | Jul 19, 2002 | SESE |
| K011441 | JAS CALCIUM (ARSENAZO) REAGENT | Jas Diagnostics, Inc. | Jul 9, 2001 | SESE |
| K983789 | CARESIDE CALCIUM, ORIGINAL | Careside, Inc. | Dec 17, 1998 | SESE |
| K981794 | HICHEM CALCIUM REAGENT KIT | Hichem Diagnostics | Jul 29, 1998 | SESE |
Top Applicants
- Harleco — 4 clearances
- Abbott Laboratories — 2 clearances
- Data Medical Associates, Inc. — 2 clearances
- HORIBA ABX SAS — 2 clearances
- Hichem Diagnostics — 2 clearances
