Vitros Chemistry Products Ca DT Slides and DT Calibrator Kit and Vitros Ca Assay
FDA 510(k) K072443 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK072443
Submission
- Device name
- Vitros Chemistry Products Ca DT Slides and DT Calibrator Kit and Vitros Ca Assay
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- August 30, 2007
- Decision date
- September 24, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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
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| 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 |
| K120626 | Eon Calcium RegentCJY · Traditional | Vital Diagnostics (Manufacturing) Ptyltd | 08/22/2012SE |
| 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 |
| K072440 | Vitros Chemistry Products: Ca Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188…CJY · Special | Ortho-Clinical Diagnostics, Inc. | 09/20/2007SE |
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Questions and answers
When was Vitros Chemistry Products Ca DT Slides and DT Calibrator Kit and Vitros Ca Assay cleared by the FDA?
Vitros Chemistry Products Ca DT Slides and DT Calibrator Kit and Vitros Ca Assay (K072443) received a 510(k) decision of Substantially Equivalent on September 24, 2007, 25 days after the submission was received.
What is the product code of K072443?
The FDA product code is CJY – Azo Dye, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.