VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
FDA 510(k) K182072 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK182072
Submission
- Device name
- VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- August 1, 2018
- Decision date
- October 30, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
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| K170320 | Alinity c ICT Sample DiluentCGZ · Traditional | Abbott Laboratories | 10/24/2017SE |
| K162020 | VITROS Chemistry Products Cl- SlidesCGZ · Traditional | Ortho Clinical Diagnostics | 12/16/2016SE |
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| K060108 | Cobas Integra Chloride Elctrode GEN.2CGZ · Special | Roche Diagnostics Corp. | 02/16/2006SE |
| K052027 | Opti Lion Electrolyte Analyzer, Model GD7200CGZ · Traditional | Osmetech, Inc. | 09/29/2005SE |
| K020148 | pHoenix ISE Reagents FOR Olympus AU Chemistry SystemsCGZ · Traditional | Phoenix Diagnostics, Inc. | 02/04/2002SE |
| K013451 | Phoenoix Ise Reagents for Roche Hitachi, Models 700/900 SeriesCGZ · Traditional | Phoenix Diagnostics, Inc. | 12/18/2001SE |
| K003664 | Delfia Neonatal Irt Kit, Model A005-110CGZ · Traditional | Wallac OY | 02/14/2001SE |
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Questions and answers
When was VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides cleared by the FDA?
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides (K182072) received a 510(k) decision of Substantially Equivalent on October 30, 2018, 90 days after the submission was received.
What is the product code of K182072?
The FDA product code is CGZ – Electrode, Ion-Specific, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.