Eon Calcium Regent
FDA 510(k) K120626 · Vital Diagnostics (Manufacturing) Ptyltd
510(k) numberK120626
Submission
- Device name
- Eon Calcium Regent
- Applicant
- Vital Diagnostics (Manufacturing) Ptyltd
Noble Park, AU - Received
- March 1, 2012
- Decision date
- August 22, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CJY – Azo Dye, Calcium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1145
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CJY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K244042 | Calcium2CJY · Traditional | Abbott Ireland | 02/10/2025SE |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeCJY · Traditional | Horiba Abx SAS | 07/26/2019SE |
| K182042 | Randox Calcium (Ca)CJY · Traditional | Randox Laboratories, Ltd. | 10/23/2018SE |
| K151113 | ELITech Clinical Systems CALCIUM ARSENAZOCJY · Traditional | Elitechgroup | 07/22/2015SE |
| K123171 | Abx Pentra Calcium AS CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…CJY · Abbreviated | Horiba Abx SAS | 07/03/2013SE |
| K083386 | Advia Chemistry CALCIUM_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N 02189915…CJY · Traditional | Siemens Healthcare Diagnostics | 04/02/2009SE |
| K072356 | S-Test CaCJY · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 06/24/2008SE |
| K073355 | Calcium, Scal, Nortrol, AbtrolCJY · Traditional | Thermofisher Scientific OY | 02/28/2008SE |
| K072443 | Vitros Chemistry Products Ca DT Slides and DT Calibrator Kit and Vitros Ca AssayCJY · Special | Ortho-Clinical Diagnostics, Inc. | 09/24/2007SE |
| K072440 | Vitros Chemistry Products: Ca Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188…CJY · Special | Ortho-Clinical Diagnostics, Inc. | 09/20/2007SE |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K112416 | CPK ReagentCGS · Traditional | 11/09/2011SE |
| K111063 | Vital Serum ControlsJJY · Traditional | 06/28/2011SE |
| K110394 | Atac Serum Calibrator (Direct Bilirubin and Iron)JIX · Abbreviated | 06/09/2011SE |
| K100060 | Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475KHS · Traditional | 12/15/2010SE |
Questions and answers
When was Eon Calcium Regent cleared by the FDA?
Eon Calcium Regent (K120626) received a 510(k) decision of Substantially Equivalent on August 22, 2012, 174 days after the submission was received.
What is the product code of K120626?
The FDA product code is CJY – Azo Dye, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.