Nova 3 Chloride/Total Dioxide Analyzer
FDA 510(k) K790653 · Nova Corp.
510(k) numberK790653
Submission
- Device name
- Nova 3 Chloride/Total Dioxide Analyzer
- Applicant
- Nova Corp.
Mchenry, IL, US - Received
- April 5, 1979
- Decision date
- June 15, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS…CGZ · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/30/2018SE |
| 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 |
| K082099 | Vitros Chemistry Products Ci-Dt Slides; Vitros Chemistry Products DT Calibrator Kit…CGZ · Special | Ortho-Clinical Diagnostics, Inc. | 08/21/2008SE |
| K070889 | Autodelfia Neonatal Irt L Kit, Model B022-112CGZ · Traditional | Wallac OY | 04/14/2008SE |
| K070531 | Ise Module and Bar Code Reader Addition for the Datapro Clinical Chemistry AnalyzerCGZ · Traditional | Thermo Fisher Scientific | 09/04/2007SE |
| 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 |
Questions and answers
When was Nova 3 Chloride/Total Dioxide Analyzer cleared by the FDA?
Nova 3 Chloride/Total Dioxide Analyzer (K790653) received a 510(k) decision of Substantially Equivalent on June 15, 1979, 71 days after the submission was received.
What is the product code of K790653?
The FDA product code is CGZ – Electrode, Ion-Specific, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.