Phoenoix Ise Reagents for Roche Hitachi, Models 700/900 Series
FDA 510(k) K013451 · Phoenix Diagnostics, Inc.
510(k) numberK013451
Submission
- Device name
- Phoenoix Ise Reagents for Roche Hitachi, Models 700/900 Series
- Applicant
- Phoenix Diagnostics, Inc.
Natick, MA, US - Received
- October 18, 2001
- Decision date
- December 18, 2001
- 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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| 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 |
| K003664 | Delfia Neonatal Irt Kit, Model A005-110CGZ · Traditional | Wallac OY | 02/14/2001SE |
More from Wallac OY
| 510(k) | Device | Decision |
|---|---|---|
| K023268 | Phoenix Ise Standard A,B and C for Roche/Avl SystemsJIX · Traditional | 11/15/2002SE |
| K020364 | Phoenix Ise Reagents for Beckman CX SystemsJGS · Traditional | 06/04/2002SE |
| K020148 | pHoenix ISE Reagents FOR Olympus AU Chemistry SystemsCGZ · Traditional | 02/04/2002SE |
| K020129 | Phoenix Eletrolyte Calibration Set for the Roche Cobas Ise ModuleJIX · Traditional | 02/01/2002SE |
| K012987 | Phoenix Electrolyte Calibration Set for the Medical Easylyte Calcium AnalyzerJIX · Traditional | 11/07/2001SE |
| K012509 | Phoenix Electrolyte Calibration Set for the Dade/Behring/Behring Dimension Chemistry…JIX · Traditional | 10/09/2001SE |
| K960592 | Electrolyte StandardsJJR · Traditional | 05/13/1996SE |
| K945860 | Spectrum Co-Oximeter Linearity ControlJJS · Traditional | 01/17/1995SE |
| K920285 | Blood Gas/Ise Linearity ControlJJS · Traditional | 07/14/1992SE |
| K912718 | Enzyme Linearity ControlJJY · Traditional | 09/06/1991SE |
Questions and answers
When was Phoenoix Ise Reagents for Roche Hitachi, Models 700/900 Series cleared by the FDA?
Phoenoix Ise Reagents for Roche Hitachi, Models 700/900 Series (K013451) received a 510(k) decision of Substantially Equivalent on December 18, 2001, 61 days after the submission was received.
What is the product code of K013451?
The FDA product code is CGZ – Electrode, Ion-Specific, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.