510(k) K083386
- Device
- ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
- Applicant
- SIEMENS HEALTHCARE DIAGNOSTICS
- 510(k) number
- K083386
- Product code
- CJY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-04-02
- Date received
- 2008-11-17
- Regulation
- 862.1145
- Classification name
- Azo Dye, Calcium
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL BIANCA
- Address
- 511 Benedict Ave. Tarrytown NY US 10591 10591
FDA Registration Numbers#
- 8020316
- 2030861
- 1181121
- 9680746
- 2050012
- 3005333358
- 2432235
- 1319809
- 3012963943
- 2250051
- 1319808
- 8040374
- 2247288
- 3007662974
- 3011989923
- 3004493545
- 2939693
- 3016438761
- 3002642396
- 3003593973
- 2050010
- 2032112
- 2085064
- 1616487
- 1220972
- 1319681
- 3000308930
- 3006716639
- 3000148879
Source Documents#
Other 510(k) Records For Product Code CJY #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary